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| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00000378 | completed | 1 | phase 4 | ['depression', 'melancholia'] | ["['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['sertraline', 'nortriptyline'] | ['CN[C@H]1CC[C@@H](C2=CC(Cl)=C(Cl)C=C2)C2=CC=CC=C12', 'CNCCC=C1C2=CC=CC=C2CCC2=CC=CC=C12'] | Inclusion Criteria: - Patients must have: Unipolar major depression (per Diagnostic and Statistical Manuel-IV criteria) with or without melancholia. Exclusion Criteria: - Patients with the following symptoms or conditions are excluded: Psychotic or atypical subtype of unipolar major depression. | |
| 2 | NCT00001656 | completed | 1 | phase 4 | ['childhood schizophrenia', 'psychotic disorder', 'schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']", "['F23', 'F24', 'F12.159', 'F12.259', 'F12.150', 'F12.151', 'F12.250']", "['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['olanzapine', 'clozapine'] | ['[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C', 'CN1CCN(CC1)C1=NC2=CC(Cl)=CC=C2NC2=CC=CC=C12'] | - INCLUSION CRITERIA: Males and females, age 7 to 18 years Onset of psychotic symptoms before 13th birthday and a DSM-IV diagnosis of either schizophrenia, schizoaffective disorder, MDI syndrome, or psychosis NOS (not otherwise specified). Current significant impairment due to the illness (current psychotic symptoms, decline of functioning academically and socially, significant discomfort due to psychotic symptoms). Failure of two prior trials with antipsychotic medications (either typical or atypical) used at adequate doses (greater than or equal to 100 mg/day in chlorpromazine equivalents) and for adequate duration (at least 4 weeks, unless terminated due to intolerable side effects). Failure is defined as either insufficient response with persistence of symptoms significantly impairing child's functioning, according to child's and parental reports and medical and school records, or intolerable side effects to drugs other than clozapine and olanzapine. Subjects may be included if their previous trial(s) of olanzapine failed to reach the dose of 20. mg/day or a duration of fewer than four weeks. Subjects may be included if their previous trial(s) of clozapine failed to reach the dose of 200. mg/day or a duration of fewer than six weeks. Comorbid psychiatric disorders in the past 12 months are permitted as long as not clinically significant. EXCLUSION CRITERIA: Prepsychotic full-scale IQ less than 70. Unstable major neurological or medical conditions. Current pregnancy or plan to become pregnant during the first three months (the duration of the study) in woman of childbearing age; breast-feeding in woman with infants. DSM-IV substance abuse or dependence in the past 6 months. True non-responders to either olanzapine or clozapine. True non-response is defined as: a) intolerance to either of the medications preventing an adequate trial, or b) only minimal (less than 20%) benefit with the adequate trial of either of the medications. Adequate trial constitutes at least 8 weeks of the medication with the dose of 20 mg on olanzapine or 200 mg of clozapine. | |
| 3 | NCT00002863 | terminated | insufficient accrual | 0 | phase 1 | ['sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['chemotherapy'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | DISEASE CHARACTERISTICS: Biopsy-proven soft tissue sarcoma (STS) of the extremity Review by Pathology Department of the University of Southern California CT or MRI required prior to biopsy Disease in one of the following categories: High-grade tumor Low-grade tumor at high risk for local recurrence, i.e.: Adjacent to bone or vital neurovascular structures and able to be removed with a minimal surgical margin (i.e., plane of dissection goes through reactive zone of tumor) Lesion more than 5 cm in diameter The following tumors exclude: Primary sarcoma of the bone Metastatic carcinoma STS of the head and neck Visceral STS, e.g., breast, uterus, spermatic cord, mediastinum chest wall STS of the pelvis or retroperitoneum PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hemoglobin at least 9 g/Dl Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times normal Renal: Not specified Other: No concurrent disease that renders patient medically or psychologically unable to tolerate treatment PRIOR CONCURRENT THERAPY: At least 30 days since therapy for sarcoma |
| 4 | NCT00003060 | terminated | lack of patient accrual | 0 | phase 1 | ['melanoma (skin)'] | ["['C43.51', 'C43.9', 'C43.52', 'D03.51', 'C43.8', 'Z85.820', 'D03.52']"] | ['busulfan', 'cyclophosphamide', 'cyclosporine', 'methotrexate'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O'] | DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor (5- or 6-antigen match) No history of CNS metastases PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1 greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B negative PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease |
| 5 | NCT00003567 | terminated | slow accrual | 0 | phase 1 | ['brain and central nervous system tumors', 'lymphoma', 'unspecified adult solid tumor, protocol specific'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['o6-benzylguanine', 'carmustine', 'temozolomide'] | ['N=C1NC2=C(N=CN2)C(OCC2=CC=CC=C2)=N1', 'ClCCNC(=O)N(CCCl)N=O', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | DISEASE CHARACTERISTICS: - One of the following histologically confirmed diseases for which no curative surgical, radiotherapy, or chemotherapy programs are available and standard therapy offers, at best, a modest clinical benefit - Solid tumors - Gliomas - Non-Hodgkin's lymphoma - Primary and metastatic CNS malignancies are eligible - Evaluable or measurable disease - CD34 count at least 2.0 cells/μL - No bone marrow involvement - Histologically negative bone marrow biopsy PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and ALT less than 2.5 times normal - Prothrombin time less than 1.2 times normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No acute cardiac disease by EKG Pulmonary: - No symptomatic pulmonary disease Other: - HIV negative - No other severe comorbid conditions - Not pregnant or nursing - Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: - See Chemotherapy - No prior hematopoietic stem cell transplantation Chemotherapy: - No prior high-dose chemotherapy - Prior adjuvant chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to 25% or more of bone marrow Surgery: - Not specified Other: - At least 4 weeks since prior myelosuppressive therapy |
| 6 | NCT00003926 | terminated | withdrawn due to slow accrual | 0 | phase 1 | ['brain and central nervous system tumors', 'childhood germ cell tumor', 'chordoma', 'kidney cancer', 'liver cancer', 'neuroblastoma', 'ovarian cancer', 'retinoblastoma', 'sarcoma'] | ["['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']", "['D17.71', 'D30.00', 'D30.01', 'D30.02', 'D41.00', 'D41.01', 'D41.02']", "['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['amifostine trihydrate', 'busulfan', 'filgrastim', 'melphalan', 'thiotepa'] | ['NCCCNCCSP(O)(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@]12CC3=C(C=C(OC)C=C3)[C@@]3(CCCC[C@]13[H])CCN2C'] | Inclusion Criteria: - Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including: - Metastatic or relapsed Ewing's sarcoma - Metastatic or relapsed rhabdomyosarcoma - Refractory Wilms' tumor - Diffuse anaplastic Wilms' tumor - Stage III or IV neuroblastoma - Recurrent retinoblastoma - Metastatic or relapsed germ cell tumors - Metastatic or relapsed other soft tissue sarcomas - Small cell ovarian sarcoma - Metastatic or relapsed primitive neuroectodermal tumors of the bone - Recurrent brain tumors - Desmoplastic small round cell tumors - Recurrent or metastatic chordomas - Metastatic or relapsed hepatoblastoma - Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression - Must have radiologic, nuclear image, or histologic verification of relapse - Age 1 to 45 - Performance status:Karnofsky 70-100% - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin count at least 10 g/dL - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT or SGPT less than 2.5 times ULN - Creatinine less than 2 times ULN - Creatinine clearance greater than 70 mL/min - Cardiac shortening fraction greater than 30% - Cardiac ejection fraction greater than 45% - At least 1 week since prior hematopoietic growth factor and recovered - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - Recovered from any prior therapy Exclusion Criteria: - Osteogenic sarcoma - Less than 4 months - Uncontrolled bleeding - Congestive heart failure - Uncontrolled hypertension - Asthma - Pregnant or nursing - Uncontrolled metabolic disease - Active severe infection - Allergy to aminothiol compounds - Prior bone marrow transplantation - Other concurrent investigational agents |
| 7 | NCT00004239 | terminated | poor accrual | 0 | phase 1 | ['chronic myeloproliferative disorders', 'leukemia', 'lymphoma', 'multiple myeloma and plasma cell neoplasm', 'myelodysplastic syndromes'] | ["['D47.1']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C96.20', 'C96.29', 'D47.09']", "['D46.9', 'D46.C', 'D46.Z']"] | ['compound 506u78'] | ['COC1=NC(N)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O'] | DISEASE CHARACTERISTICS: Histologically confirmed hematologic malignancy that has failed standard therapy or for which no standard therapy exists, including, but not limited to, the following: Acute lymphocytic leukemia Acute myelogenous leukemia Chronic lymphocytic leukemia Chronic myelogenous leukemia Multiple myeloma Non-Hodgkin's lymphoma Hodgkin's disease No history of CNS disease, including carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin: Groups 1-4: Less than 1.5 times upper limit of normal (ULN) Group 5: 1.5-4 times ULN Renal: Creatinine clearance: Groups 1 and 5: Greater than 50 mL/min Group 2: 30-50 mL/min Group 3: Less than 30 mL/min Group 4: Less than 30 mL/min, requiring dialysis Neurologic: No history of grade 2 peripheral neuropathy No history of seizure disorder No history of neurologic dysfunction Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (e.g., interferon, monoclonal antibodies) No concurrent interleukin-11 for treatment or prevention of thrombocytopenia No concurrent prophylactic colony stimulating factors Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for melphalan, carmustine, or mitomycin) At least 72 hours since prior hydroxyurea No prior 506U78 No other concurrent chemotherapy Endocrine therapy: At least 72 hours since prior glucocorticoids Concurrent continuation of steroids for adrenal failure allowed No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy No concurrent whole brain irradiation for documented CNS disease Surgery: Not specified Other: At least 72 hours since prior aspirin |
| 8 | NCT00005612 | terminated | low accrual | 0 | phase 1/phase 2 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['carboplatin', 'cyclophosphamide', 'etoposide', 'paclitaxel', 'topotecan hydrochloride'] | ['COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', '[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: Histologically proven stage IIIC ovarian epithelial cancer Chemosensitive to 6-8 courses of standard dose adjuvant chemotherapy (one regimen), such as cisplatin or carboplatin in combination with paclitaxel, or any other standard dose regimen Residual disease (no greater than 1 cm) following second look laparotomy Ineligible if no microscopic disease present following induction chemotherapy OR Histologically proven newly diagnosed stage IV ovarian epithelial cancer Achieved at least partial response (PR) (80% or greater reduction in tumor by CT scan) following six courses of standard dose chemotherapy (one regimen) OR Residual disease (no greater than 1 cm) or no disease determined at the time of second look laparotomy OR Histologically proven relapsed ovarian epithelial cancer Relapse following standard dose chemotherapy Chemosensitive Achieved at least PR after 4-6 courses of salvage chemotherapy (total of 2 regimens) No more than a six week interval between completion of standard dose chemotherapy and second look laparotomy PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL ALT or AST no greater than 2.5 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction at least 50% by MUGA scan No severe cardiac dysfunction or major heart disease No angina pectoris No ventricular dysrhythmias Essential hypertension allowed if controlled with medication(s) Pulmonary: DLCO at least 50% predicted No symptomatic obstructive or restrictive pulmonary disease Other: No active infections HIV negative No uncontrolled insulin dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No other malignancy within the past 5 years except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior topotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent nitroglycerin preparations or antiarrhythmic drugs |
| 9 | NCT00006170 | completed | 1 | phase 4 | ['tobacco use disorder'] | ["['Z72.0', 'P04.2']"] | ['bupropion', 'placebo'] | ['CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1'] | Inclusion Criteria: - Smoke at least 10 cigarettes per day - Report concern about cessation-related weight gain - Motivated to quit smoking Exclusion Criteria: - Currently pregnant, lactating, or no medically approved method of contraception - Major medical problem - History of seizure disorder or head injury - Current or historical psychosis or bipolar disorder - History of alcohol or substance abuse within previous year - Current or historical eating disorder - Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month - Multiple Drug Allergies - Current major depressive disorder | |
| 10 | NCT00007475 | completed | 1 | phase 1/phase 2 | ['focal segmental glomerulosclerosis'] | ["['K55.021', 'K55.041', 'M99.00', 'M99.01', 'M99.02', 'M99.03', 'M99.04']"] | ['cyclophosphamide'] | ['[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | - INCLUSION CRITERIA: 1. Patients with idiopathic focal segmental glomerulosclerosis on renal biopsy, including the following categories: A) Untreated FSGS B) Steroid-dependent FSGS C) Steroid resistant FSGS D) Recurrent FSGS, with functioning allograft E) FSGS in ESRD, receiving hemodialysis 2. Adults greater than or equal to18 will be eligible for all studies. 3. Children greater than 20 kilograms, will be eligible for all branches of the study except for treatment of steroid resistant FSGS with pirfenidone, as pirfenidone has not previously been administered to pediatric patients in any setting. Children less than 20 kilograms will be excluded from the study for the following reason: plasma exchange in patients less than 20 kilograms requires a red blood cell transfusion, which significantly increases the risk of the procedure by exposing the patient to the risk of transfusion associated infections, and the safety of an aggressive course of plasma exchange has not been established in this population. EXCLUSION CRITERIA: 1. Secondary FSGS: HIV-associated FSGS or hyperfiltration FSGS, including FSGS associated with congenital renal abnormalities, renal mass reduction, reflux nephropathy, interstitial nephritis, and sickle cell anemia are excluded. 2. Patients with disease associated with immunosuppression, other than chronic renal failure. 3. The presence of malignancy or the history of other serious, complicating illness such as myocardial infarction or cerebrovascular accident in the past six months, at the discretion of the investigators. 4. For plasma exchange: A Department of Transfusion Medicine consultant will evaluate all potential plasma exchange patients. Those with prolonged PT, PTT, platelet count less than 100,000 or receiving anticoagulant therapy will undergo plasma exchange only if the consultant considers this to be safe. 5. For prednisone: uncontrolled diabetes mellitus (requiring greater than 100 units of insulin/day with the concurrence of the Endocrinology consultant), active infection including hepatitis B or C (if that is the advice of the Hepatology consultant), infection with HIV (as these patients are at increased risk of avascular necrosis), other active infection (if that is the advice of the Infectious Disease consultant), history of avascular necrosis or bone densitometry indicating bone mass less than 2SD below normal, active ulcer disease, history of steroid-induced psychosis, morbid obesity, positive PPD or history of past positive PPD without adequate treatment are excluded. 6. For Cyclophosphamide: A) Allergy or hypersensitivity to cyclophosphamide B) Leukocyte less than 3000 cells/microliter or ANC less than 1500 cells/microliter or evidence of bone marrow compromise C) Prior irradiation to the heart or therapy with doxorubicin or other cardiotoxic medication (may increase the risk for cardiotoxicity) D) Peritoneal dialysis, as there is no published evidence that cyclophosphamide metabolites can be safely removed. E) Certain drugs will be used with caution or avoided. Barbiturates and phenytoin induce the hepatic enzymes that metabolize cyclophosphamide and therefore if these medications are required, cyclophosphamide doses may need to be increased to achieve a comparable immunosuppressive effect. Drugs that inhibit cyclophosphamide metabolism include allopurinol, imipramine, and phenothiazines, chloramphenicol and chlorpromazine; these drugs will be avoided. NSAID increase the risk of hyponatremia; these drugs will be avoided. | |
| 11 | NCT00023673 | completed | 0 | phase 1/phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'paclitaxel'] | ['COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', 'CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma - Non-small cell carcinoma not otherwise specified - All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields - Measurable disease on 3-dimensional planning CT scan - No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma - No stage IV or recurrent disease - No distant metastases or supraclavicular lymph node involvement - No significant atelectasis (i.e., atelectasis of an entire lung) - No pleural effusions, pericardial effusions, or superior vena cava syndrome - No lung cancer within the past 2 years - Ineligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - Aspartate aminotransferase (AST) less than 2 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Pulmonary: - Forced expiratory volume (FEV)_1 at least 1.0 L Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No weight loss greater than 5% in the past 6 months - No other malignancy within the past year except nonmelanoma skin cancer - Completed 3D plan with total lung V20 </= 30% mean esophageal dose </= 34 Gy and esophageal V55 </= 30% PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic response modifiers for current lung cancer - At least 5 years since prior biologic response modifiers Chemotherapy: - No prior chemotherapy for current lung cancer - At least 5 years since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the thorax Surgery: - No prior complete tumor resection | |
| 12 | NCT00042991 | completed | 1 | phase 1/phase 2 | ['untreated childhood anaplastic astrocytoma', 'untreated childhood anaplastic oligodendroglioma', 'untreated childhood brain stem glioma', 'untreated childhood giant cell glioblastoma', 'untreated childhood glioblastoma', 'untreated childhood gliomatosis cerebri', 'untreated childhood gliosarcoma', 'untreated childhood oligodendroglioma'] | ["['C84.67', 'C84.77', 'C84.60', 'C84.70', 'C84.62', 'C84.66', 'C84.72']", "['C84.67', 'C84.77', 'C84.60', 'C84.70', 'C84.62', 'C84.66', 'C84.72']", "['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']", "['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']", "['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']", "['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']", "['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']", "['F80.81', 'F84.3', 'F93.8', 'F93.9', 'R62.0', 'E71.520', 'F64.2']"] | ['gefitinib'] | ['COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | Inclusion Criteria: - Tumor: - Phase I: newly diagnosed non-disseminated diffuse intrinsic brainstem tumor or newly diagnosed (diagnostic scan must be within 4 weeks prior to treatment initiation), incompletely resected supratentorial malignant glioma (anaplastic astrocytoma, glioblastoma multiforme or other high-grade glioma) (STMG); the STMG group must have residual tumor evident on postoperative MRI or CT - Phase II: only newly diagnosed non-disseminated diffuse intrinsic brain stem glioma patients are eligible - Performance status: Karnofsky or Lansky >= 50% assessed within two weeks prior to registration - Prior/concurrent therapy: - Chemotherapy: no prior therapy allowed, including prior gefitinib treatment - Radiation therapy (XRT): no prior therapy allowed - Bone marrow transplant: none prior - Anti-convulsants: patients with brain stem glioma (BSG) receiving EIACD will not be eligible; patients with STMG will be eligible for this study even if they are receiving enzyme inducting anti-convulsant drugs (EIACD) and will be stratified by use of EIACDs - Growth factors: off all colony forming growth factor(s) > 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin) - ANC > 1,000/ul - Platelets > 100,000/ul (transfusion independent) - Hemoglobin > 8g/dl (may be transfused) - Patients may have bone marrow involvement by disease - Creatinine < 2 x normal for age or GFR > 70 ml/min/1.73m^2 - Bilirubin < 1.5 x normal institutional normal for age - SGPT (ALT) < 3 x institutional normal for age - Pregnant and/or lactating patients are excluded; patients of childbearing potential should not become pregnant and should not father a child during treatment with gefitinib; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method - Signed informed consent according to institutional guidelines must be obtained prior to study entry Exclusion Criteria: - Patients with evidence of intramural hemorrhage on a scan obtained prior to enrollment or after enrollment, before treatment - Patients with BSG must not be taking enzyme-inducing anticonvulsant drugs - Patient must not be receiving any other anticancer or experimental drug therapy - Patient must have no uncontrolled infection - Patients with significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or psychiatric disease are ineligible; patients with deep venous or arterial thrombosis within 6 weeks of study entry are ineligible - Patients with disseminated disease are not permitted - Patients with spinal disease requiring craniospinal radiation are not eligible - Patients with completely resected supratentorial malignant gliomas patients are ineligible | |
| 13 | NCT00046475 | completed | 1 | phase 4 | ['hypotension, orthostatic'] | ["['I95.1']"] | ['midodrine hydrochloride'] | ['COC1=CC(C(O)CNC(=O)CN)=C(OC)C=C1'] | Inclusion Criteria: - The male or female patient must be 18 years of age or older and ambulatory. - Female patients must be: without menses for at least 12 months prior to screening; surgically sterilized (bilateral tubal ligation or hysterectomy); or practicing adequate means of birth control. Adequate means of birth control is defined as the use of prescribed birth control pills, IUD, or hormonal injections from at least one month prior to screening. Double-barrier methods and abstinence are also acceptable forms of birth control. - The patient has been diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). - The patient manifests at least one of the following symptoms while standing or has a history of one of the following when not treated for orthostatic hypotension: dizziness, lightheadedness, feeling faint or feeling like they may black out. - The patient is willing and able to undergo the procedures required by this protocol including morning office visits, assessment completion, protocol compliance and participation in the wash-out period. - The patient signs an Institutional-Review-Board approved written Informed Consent form prior to any study procedures taking place. Exclusion Criteria: - The patient is pregnant or lactating female. - The patient has pre-existing sustained supine hypertension greater than 180 systolic and 110 diastolic mmHg. - The patient is taking medications such as vasodilators, pressors, diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, MAOI's, herbals, or specific mixed effect medications. - The Principal Investigator deems any laboratory test abnormality clinically significant. - The patient has a diagnosis of any of the following disorders at the time of screening: pheochromocytoma; cardiac conditions including: congestive heart failure within the previous 6 months, myocardial infarction within the previous 6 months, symptomatic coronary artery disease, history of ventricular tachycardia, or uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus (uncontrolled defined as HgbA1c greater than or equal to 10%); history of cerebrovascular accident, transient ischemic attack (TIA) or symptomatic carotid artery stenosis within the previous 6 months; history of coagulopathies; pulmonary hypertension; severe psychiatric disorders; renal failure (creatinine equal to or greater than 2 times the upper limit of normal). - The patient has a concurrent chronic or acute illness, disability, or other condition that might confound the results of the tests and/or measurements administered in this trial, or that might increase the risk to the patient. | |
| 14 | NCT00048399 | terminated | accrual was slow | 0 | phase 1/phase 2 | ['graft failure'] | ["['T86.831', 'T86.821']"] | ['fludarabine', 'campath 1h', 'fk506'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CO[C@@H]1C[C@@H](CC[C@H]1O)\\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC'] | INCLUSION CRITERIA - Diagnosis of engraftment failure either primary or secondary, following allogeneic transplantation. Graft failure is defined as absolute neutrophil count < 500/mm3 and/or platelet count < 20,000/mm3. Primary graft failure is defined as failure to maintain absolute neutrophil count > / = 500/mm3 for 3 consecutive days following allogeneic transplantation. Secondary graft failure is defined as failure to sustain an absolute neutrophil count > / = 500/mm3 after attainment of primary engraftment or failure to sustain platelet count > / = 20,000/mm3 despite neutrophil engraftment. For SCID patients, graft failure is defined as failure to recover > / = 500/mm3 T-cells and/or failure to generate satisfactory response to in vitro mitogen stimulation. For patients with genetic diseases, engraftment failure is defined as donor chimerism insufficient to correct or overcome the genetic or metabolic deficiency. - Available Healthy Donor without any contraindications for donation (5/6 or 6/6 related donor or 5/6 or 6/6 unrelated donor (molecular typing for DRB1) - Age between birth and 65 - For women of childbearing potential, negative pregnancy test EXCLUSION CRITERIA - Pregnant and lactating women or women unwilling to use contraception. - Uncontrolled intercurrent infection - Refractory AML or ALL - Untreated Blast Crisis for CML - Uncontrolled High-grade lymphoproliferative disease/lymphoma - Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater) - Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater) - Hemodialysis dependent - Active Hepatitis or cirrhosis with total bilirubin, SGOT, or SGPT greater than 3 x normal. - Concurrent solid organ malignancy not in remission, except for Stage 0 or A prostate cancer. - Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months) - Active CNS disease from hematological disorder. |
| 15 | NCT00048893 | terminated | the study was closed to accrual due to very poor enrollment. | 0 | phase 1/phase 2 | ['breast neoplasms', 'metastases, neoplasm'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['cyclophosphamide', 'doxorubicin hydrochloride', 'fludarabine phosphate', 'paclitaxel', 'mesna'] | ['[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | - INCLUSION CRITERIA: All patients must have a diagnosis of metastatic infiltrating carcinoma of the breast including hormone receptor testing. At least one site of metastatic disease must have been confirmed by pathologic or cytologic material. In the choice of a biopsy site, the PI will weigh the morbidity the diagnostic procedure against the probability of positive yield of the diagnostic procedure. All pathologic material must be reviewed by the Pathology Laboratory of the National Cancer Institute (NCI) before treatment. The tumor MUST stain positive for CEA, by standard immuno-histochemistry performed at the Pathology Laboratory of the NCI. --Method: 5 microM formalin-fixed paraffin-embedded sections are deparaffinized and blocked with methanol-30% hydrogen peroxide (H2O2). After antigen retrieval by boiling in citrate buffer, or heating in a microwave oven for 10 minutes, slides are incubated with monoclonal antibodies anti-CEA (diluted 1/1000 Dako). Then, slides are immunostained with avidin-biotin-peroxidase complex and developed with diaminobenzidine. Harris' hematoxylin was used to counter stain the slides. Positivity is defined as greater than 30% of cells staining. Patients may be newly diagnosed with metastatic breast carcinoma or known to have breast carcinoma. - If newly diagnosed, patients may not have received any chemotherapy for this disease before entry on study. - If previously treated for breast cancer, patients may have received chemotherapy or radiation as adjuvant treatment for non-metastatic disease or metastatic disease but not in the previous 18 months. - Patients may have been on hormonal therapy for stage IV disease. Patients with disease progression on hormonal therapy alone are eligible. Karnofsky performance status of greater than or equal to 70% (Eastern Cooperative Oncology Group (ECOG) 0 or 1) Ejection fraction by multi-gated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram within normal institutional limits. In case of insufficient ejection fraction, a stress echocardiogram will be performed. In case of an ejection fraction greater than 35 % but less than 45%, the patient will remain eligible for the study if the increase of ejection fraction with stress is estimated at 10% or more. Creatinine clearance greater than or equal to 60 cc/min Normal urinalysis; if proteinuria is present it must be quantified at less than 1 g / 24 h on a measured 24 h urine collection Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal except if believed to be due to tumor involvement of the liver prior to induction therapy. Bilirubin less than 1.5 (except if due to tumor involvement prior to induction therapy or in cases of Gilbert's disease). Absolute Neutrophil Count greater than l000 / mm^3 and Platelet count greater than 90,000 Corrected carbon monoxide diffusing capacity (DLCO) greater than 50% No history of abnormal bleeding tendency or predisposition to repeated infections. Patient must be able to avoid close contact with children under 3 years old, pregnant women, individuals with eczema or other skin conditions, and immuno-suppressed people for 2 weeks after initial vaccination. (see protocol for specific exclusion criteria for vaccinia administration). Patients must agree to make specific arrangements, if necessary, in order to comply and be eligible. Patients must be able to give informed consent. EXCLUSION CRITERIA: Age less than 18 years Patients in whom an urgent or emergent clinical situation does not safely allow for the short delay in initiating the Concurrent Therapy (as defined in protocol) necessary for the pre-treatment immunization and lymphocyte collection (at the discretion of the PI). Patients requiring chronic immunosuppressive therapy (including corticosteroids) for any medical condition. Patients with an autoimmune disease: autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren syndrome, Scleroderma, Systemic Sclerosis, Myasthenia Gravis; Multiple sclerosis, Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or active Graves' disease) Any abnormality on the following tests suggestive of an autoimmune disease: anti-nuclear antibody (ANA), anti-deoxyribonucleic acid (DNA), triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH) after review with appropriate consultant. Patients with endocrine disease that is controlled by replacement therapy including, diabetes, thyroid and adrenal disease or vitiligo may be enrolled. Patients with active inflammatory bowel disease Patients with clinically significant cardiomyopathy requiring treatment or symptomatic congestive heart failure (CHF), symptomatic arrhythmia that is not controlled by medication, unstable coronary artery disease (CAD) such as unstable angina who require active intervention, and patients with a recent infarction or cerebrovascular accident (CVA) within the past 6 months Patients testing positive for human immunodeficiency virus (HIV) or hepatitis B or C Patients known or found to be pregnant or those unwilling to discontinue breastfeeding. The effects of the chemotherapy, vaccines, and the medications used in this study are highly likely to be harmful to a fetus. The effects upon breast milk are also unknown and may be harmful to the infant; therefore, women should not breastfeed while on this study. Patients of childbearing age who are unwilling to practice an effective form of contraception. Patients of childbearing potential must use an effective method of contraception while they are on-study; effective methods include intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy (self or partner), partner's vasectomy, or barrier methods (condom, diaphragm, or cervical cap), or abstinence. Patients with brain metastases. Patients with an active second malignancy (excluding treated skin cancers or carcinoma in-situ) will be ineligible. Patients with a life expectancy reasonably estimated at less than 6 months. Patients may be excluded at the discretion of the principal investigator (PI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk. History of splenectomy Allergy to eggs Several exclusion criteria are specific to vaccinia administration: The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least two weeks after vaccination, to their close household contacts (Close household contacts are those who share housing or have close physical contact): - Persons with active or a history of eczema or other eczematoid skin disorders - Persons with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; - Pregnant or nursing women - Children under 3 years of age; - Immunodeficient or immunosuppressed persons by disease or therapy, including HIV infection. - History of seizures, encephalitis, or multiple sclerosis - History of allergy or complications with past vaccinia vaccination. |
| 16 | NCT00052884 | terminated | slow accrual and changes in clinical practice | 0 | phase 1 | ['drug/agent toxicity by tissue/organ', 'multiple myeloma and plasma cell neoplasm'] | ["['T86.91', 'T86.92', 'T86.93', 'Z52.9', 'Z94.89', 'Z94.9', 'T86.90']", "['C96.20', 'C96.29', 'D47.09']"] | ['amifostine trihydrate', 'melphalan'] | ['NCCCNCCSP(O)(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed amyloidosis - No secondary familial or localized amyloidosis - Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine - No primary amyloidosis manifested only by carpal tunnel syndrome or purpura - Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome - Amyloid syndromes include any of the following: - Hepatomegaly - Cardiomyopathy - Nephrotic range proteinuria - Peripheral or autonomic neuropathy - No multiple myeloma defined by 1 of the following: - Presence of lytic bone disease - More than 30% bone marrow plasma cells PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Platelet count at least 100,000/mm^3 Hepatic - See Disease Characteristics - Total or direct bilirubin no greater than 2.0 mg/dL - Alkaline phosphatase no greater than 4 times upper limit of normal Renal - See Disease Characteristics - Creatinine less than 3.0 mg/dL Cardiovascular - See Disease Characteristics - Ejection fraction at least 45% by echocardiogram - No New York Heart Association class III or IV heart disease - Systolic blood pressure ≥ 90 mmHg Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection - No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior interferon Chemotherapy - At least 4 weeks since prior melphalan - Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight) Endocrine therapy - At least 4 weeks since prior dexamethasone Radiotherapy - No prior radiotherapy for amyloidosis Surgery - Not specified Other - No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration - No other prior treatment |
| 17 | NCT00056862 | completed | 1 | phase 4 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['peginterferon alfa-2a', 'peginterferon alfa-2a', 'ribavirin'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | - INCLUSION CRITERIA: Age above 18 years, male or female. Presence of anti-HCV in serum. Positive HCV RNA determination in serum. HCV genotype 2 or 3 as determined by Inno LiPa assay or by direct sequencing. Patients with mixed genotypes will not be eligible if they have genotypes other than 2 or 3. Written informed consent. EXCLUSION CRITERIA: Previous treatment with interferon alpha or peginterferon. Decompensated liver disease, as marked by bilirubin greater than 4 mg/dL, albumin less than 3.0 g/dL, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Pregnancy or, in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicidal, or birth control pills, or an intrauterine device. Significant systemic or major illnesses other than liver disease, including congestive heart failure, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease not controlled by psychotropic agents, and angina pectoris. Evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease. Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 30%), neutropenia (less than 1000 neutrophils/microliter) or thrombocytopenia (less than 70,000 cells/microliter). History of hemolytic anemia. Evidence of another form of liver disease in addition to hepatitis C (for example hepatitis B, autoimmune liver disease, Wilson's disease, alcoholic liver disease). Active substance abuse, such as alcohol, inhaled or injection drugs within the previous six months. Evidence of hepatocellular carcinoma: either alfa-fetoprotein (AFP) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer. Clinical gout. HIV infection. Quiescent or active, serious autoimmune disease such as lupus erythematosus, ulcerative colitis, Crohn's disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alfa interferon. The use of immunosuppressive medications, including corticosteroids in doses of 10 mg of prednisone or its equivalent and higher. | |
| 18 | NCT00058825 | terminated | slow accrual due to practice changes meant study would take too long to finish | 0 | phase 1/phase 2 | ['hematologic malignancies'] | ["['E70.338', 'E70.339', 'O28.0', 'P61.8', 'P61.9', 'T45.8X1A', 'T45.8X1D']"] | ['fludarabine', 'fk506 (tacrolimus) or cyclosporine'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C'] | INCLUSION CRITERIA: 1. Diagnosis of myelodysplastic disorders; Fanconi's Anemia; Acute Myelogenous Leukemia (including secondary); Acute Lymphoblastic Leukemia; Multiple Myeloma; Plasma Cell Dyscrasia; lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia, and Hodgkin's Disease). Diagnosis of myelodysplastic disorders which is not good risk by IPSS: Fanconi's Anemia; Acute Myelogenous Leukemia (1st or subsequent relapse, or 2nd or subsequent CR, or refractory disease); Acute Lymphoblastic Leukemia in 2nd or subsequent remission or relapse or refractory disease; Philadelphia Chromosome-positive Chronic Myelogenous Leukemia (failed STI and interferon); Multiple Myeloma (Stage II or III); Lymphoma; Chronic Lymphocytic Leukemia (primary refractory or recurrent disease); Hodgkin's Disease (after relapse); Hemophagocytic Lymphohistiocytosis (failed chemotherapy and/or anti-viral therapy); bone marrow failure such as Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria; PNH (failed prior therapies). 2. Conditions that increase treatment related mortality: (need one or more to be eligible): Age > / = 50 years; EF of less than 45%; DLCO less than 50% or FEVI 50-75% of predicted value; Diabetes Mellitus; Renal Insufficiency (but creatinine clearance not less than 25 mL/min); Prior recent history of systemic fungal infection; 3rd or greater remission of AML or ALL; Significant Grade III or IV neurologic or hepatic toxicity from previous treatment; More than 1 year from diagnosis (CML or Myeloma patients ONLY); Multiple types of treatment regimens (equal to or more than 3); Significant Grade III or IV neurologic or hepatic toxicity from previous treatment; Prior autologous or allogeneic stem cell transplantation. 3. Haploidentical family member donor. This protocol is open to patients who lack a 5/6 or 6/6 HLA antigen-matched donor. Due to the increased risk of GvHD, patients with Fanconi Anemia and a 5/6 HLA match will also be eligible. For this protocol, the "best" donor will be defined as a first-degree haploidentical family member who matches at the greatest number of MHC loci. Matching will be determined by Class I and Class II DNA typing. The donor should be sufficiently healthy as to not be at increased risk from the stem cell mobilization procedure. Should more than one "equally" MHC-incompatible donor be identified, other selection criteria will include: age and size of donor, CMV status, and sex. The Principal Investigator will make final decisions. 4. Available healthy donor without any contraindications for donation. 5. Patient and/or legal representative and/or legal guardian able to understand and sign consent. 6. Age between birth and 70 years. 7. Women of child-bearing potential must have a negative pregnancy test. EXCLUSION CRITERIA: 1. Pregnant, lactating or unwilling to use contraception. 2. HIV-positive patient. 3. Uncontrolled intercurrent infection. 4. Untreated blast crisis for CML. 5. Uncontrolled high-grade lymphoproliferative disease / lymphoma. 6. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater). 7. Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater). 8. Hemodialysis dependent. 9. Active hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3X upper limit of normal. 10. Unstable cerebral vascular disease and recent hemorrhagic stroke (less than 6 months). 11. Active CNS disease from hematological disorder. |
| 19 | NCT00068250 | completed | 1 | phase 1/phase 2 | ['brain and central nervous system tumors', 'lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['rituximab', 'methotrexate', 'temozolomide 100 mg/m^2', 'temozolomide 150 mg/m^2', 'temozolomide 200 mg/m^2', 'post-radiation therapy temozolomide'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | Inclusion criteria: 1. Primary central nervous system (CNS) lymphoma [B-cell, Cluster of Differentiation 20 (CD20) antigen positive] based on positive biopsy or cerebrospinal fluid (CSF) or vitreous cytology (in association with measurable intraparenchymal tumor). Cytology must demonstrate lymphoma or have an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population. 2. Life expectancy ≥ 8 weeks; 3. Zubrod performance status of 0-2; 4. Absolute granulocyte count ≥1500/mm3; platelet count ≥ 100,000/mm3; creatinine clearance ≥ 50, calculated with the Cockcroft-Gault Equation: Cr Clearance = (140-age) x wt (kg)/(Cr[mg/dl]x 72); Bilirubin, serum glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (AST) ≤ 2 x institutional upper limits of normal; 5. Patients must sign a study-specific informed consent prior to study entry. 6. Age ≥ 18 Exclusion criteria: 1. Evidence of systemic lymphoma; 2. Prior malignancy (excluding in situ carcinoma of the cervix or non-melanomatous skin cancer)unless disease free for at least five years; 3. Prior radiotherapy to the brain or head/neck; 4. Prior chemotherapy; 5. History of idiopathic sensitivity to any of the drugs to be used; 6. Active infectious process; 7. Seropositive for HIV, AIDS, or post-organ transplant; 8. Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus. 9. Active hepatitis B. | |
| 20 | NCT00076024 | completed | 0 | phase 1/phase 2 | ['breast neoplasms'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['placebo', 'docetaxel', 'ag-013736 (axitinib)', 'docetaxel'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CNC(=O)C1=C(SC2=CC=C3C(NN=C3\\\\C=C\\\\C3=CC=CC=N3)=C2)C=CC=C1'] | Inclusion Criteria: - Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease) - Adequate bone marrow, liver, and renal function Exclusion Criteria: - Adjuvant chemotherapy given in the past 12 months - Uncontrolled brain metastases | |
| 21 | NCT00077103 | terminated | slow accrual | 0 | phase 1/phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['cisplatin', 'doxorubicin hydrochloride', 'fosbretabulin disodium'] | ['CC(=O)OC1=CC=CC=C1C(O)=O', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'COC1=CC(=CC(OC)=C1OC)[C@@H](O)CC1=CC(O)=C(OC)C=C1'] | DISEASE CHARACTERISTICS: - Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following: - Regionally advanced disease - Confined to the neck and/or superior mediastinum (i.e., above the level of the carina) - Measurable or evaluable* disease - Completely resected disease without measurable or evaluable disease NOTE: *At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed - Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry - Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy - Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction - No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases - Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 75,000/mm^3 - Hemoglobin ≥ 8.5 g/dL Hepatic - Bilirubin ≤ 1.5 mg/dL - ALT and AST ≤ 3.5 times upper limit of normal Renal - Creatinine ≤ 1.5 mg/dL Cardiovascular - LVEF ≥ 50% by echocardiogram - EKG normal - No prior angina - No prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec, or other clinically significant abnormalities on ECG - No congestive heart failure - No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following: - Conduction abnormality - Nodal junctional arrhythmias and dysrhythmias - Sinus bradycardia or tachycardia - Supraventricular arrhythmias - Atrial fibrillation or flutter - Syncope or vasovagal episodes - No significant heart wall abnormality or heart muscle damage by echocardiogram - No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication) - Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry - No symptomatic peripheral vascular disease or cerebrovascular disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled hypokalemia or hypomagnesemia - No concurrent serious infection - No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy - No grade 2 or greater pre-existing motor or sensory peripheral neuropathy - No psychiatric disorder or other condition that would preclude study compliance - No conditions associated with QTc prolongation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy, except for the following: - Gonadotropin-releasing hormone agonists for patients with hormone-refractory prostate cancer - Hormone replacement therapy - Oral contraceptives - Megestrol for anorexia/cachexia Radiotherapy - No prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - Prior attempt at resection or cytoreduction (e.g., debulking) surgery irrespective of surgical margins allowed provided there are no distant metastases - At least 1 week but no more than 8 weeks since prior surgery and recovered Other - No other concurrent cytotoxic therapy - No other concurrent antineoplastic therapy - No other concurrent investigational therapy - No concurrent medications known to prolong the QTc interval unless the medication can be held for at least 4 days during each treatment course |
| 22 | NCT00077636 | completed | 1 | phase 4 | ['hepatitis c, chronic'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['copegus', 'copegus', 'peginterferon alfa-2a [pegasys]', 'peginterferon alfa-2a [pegasys]'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - patients >=18 years of age; - CHC infection (genotype 2 or 3); - liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection; - use of 2 forms of contraception during study and 6 months after the study in both men and women. Exclusion Criteria: - women who are pregnant or breastfeeding; - male partners of women who are pregnant; - conditions associated with decompensated liver disease; - other forms of liver disease, including liver cancer; - human immunodeficiency virus infection; - previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine. | |
| 23 | NCT00081887 | terminated | low accrual | 0 | phase 1 | ['chronic lymphocytic leukemia', 'leukemia'] | ["['C91.11', 'C91.12', 'C91.10']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['clofarabine'] | ['[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: 1. Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen. 2. Absolute neutrophil count (ANC) >= 1 x 10(9)/L and platelet count >= 50 x 10(9)/L 3. Adequate liver function (total bilirubin <= 1.5 x ULN, SGPT <= 2.5 x ULN) and renal function (serum creatine <= 1.5 x ULN). 4. ECOG performance status <= 2. Exclusion Criteria: 1. Patients with NYHA >= grade 3 heart disease as assessed by history and/or physical examination 2. Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. 3. Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy) 4. Other malignancy within 3 years except in situ carcinoma 5. Unwilling or unable to provide informed consent 6. Hypersensitivity to nucleoside analogues 7. Other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, ventricular arrhythmia, diabetes, active infection, pulmonary fibrosis, and chronic hepatitis |
| 24 | NCT00084136 | completed | 1 | phase 4 | ['hiv infections'] | ["['Z21']"] | ['atazanavir', 'didanosine (enteric-coated)', 'efavirenz', 'emtricitabine', 'emtricitabine/tenofovir disoproxil fumarate', 'lamivudine/zidovudine'] | ['COC(=O)N[C@H](C(=O)N[C@@H](CC1=CC=CC=C1)[C@@H](O)CN(CC1=CC=C(C=C1)C1=CC=CC=N1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C', 'OC[C@@H]1CC[C@@H](O1)N1C=NC2=C1NC=NC2=O', 'FC(F)(F)[C@]1(OC(=O)NC2=C1C=C(Cl)C=C2)C#CC1CC1', 'NC1=NC(=O)N(C=C1F)[C@@H]1CS[C@H](CO)O1', 'CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1', 'CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O'] | Inclusion Criteria :> - HIV-1 infected> - CD4 count fewer than 300 cells/mm3 > - Viral load test result> - Absolute Neutrophil Count at least 750mm3 > - Hemoglobin at least 7.5 g/dL> - Platelet count at least 50,000/mm3> - Calculated creatinine clearance at least 60 mL/min> - A , A, and alkaline phosphatase <= 5 times upper limit of normal> - total bilirubin <= 2.5 times upper limit of normal> - Karnofsky performance score of 70 or higher> - Plans to stay in the area for the duration of the study> - Agrees to use acceptable forms of contraception for the duration of the study> Exclusion Criteria:> - More than 7 days exposure to ARVs (except for single-dose NVP or ZDV for any period for the purpose of pMTCT)> - Acute therapy for serious medical illnesses within 14 days prior to study entry> - Certain abnormal laboratory values> - Radiation therapy or chemotherapy within 45 days prior to study entry. > - Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. > - Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation> - Inflamed pancreas within 3 years prior to study entry> - Allergy/sensitivity to any of the study drugs or their formulations> - Heart rate less than 40 beats/min> - History of untreated, active second- or third-degree heart block> - Currently detained in jail or for treatment of a psychiatric or physical illness> - Vomiting or inability to swallow medications> - Pregnancy> | |
| 25 | NCT00084266 | completed | 1 | phase 4 | ['methicillin resistant staphylococcus aureus (mrsa)'] | ["['A41.2', 'J15.20', 'J15.29', 'P23.2', 'A41.1', 'A41.01', 'A41.02']"] | ['linezolid (zyvox)', 'vancomycin'] | ['CC(=O)NC[C@H]1CN(C(=O)O1)C1=CC(F)=C(C=C1)N1CCOCC1', '[H][C@]1(NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](CCN)NC(=O)[C@H](CCNC1=O)NC(=O)[C@H](CCN)NC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)CCCCC(C)CC)[C@@H](C)O)[C@@H](C)O'] | Inclusion Criteria: - Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus. - Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia. - Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry. Exclusion Criteria: - Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding). - Subjects with severe neutropenia (<500 cells/mm3) - Subjects with hypersensitivity to oxazolidinones or vancomycin. | |
| 26 | NCT00084890 | terminated | slow accrual | 0 | phase 1 | ['cervical cancer'] | ["['M50.20', 'M50.21', 'M50.30', 'M50.31', 'M50.80', 'M50.81', 'M50.90']"] | ['carboplatin', 'docetaxel'] | ['COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the uterine cervix - Advanced disease (stage IVB) - Persistent or recurrent disease - No available curative treatment options - Measurable disease by physical examination, chest x-ray, CT scan, or MRI PATIENT CHARACTERISTICS: Age - Over 18 Performance status - GOG 0-2 Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 - Hemoglobin > 8 g/dL Hepatic - Bilirubin normal - SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR - Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal Renal - Creatinine < 1.5 times ULN Other - No other invasive malignancy within the past 5 years - No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No peripheral neuropathy > grade 1 - No other concurrent malignancy except curatively treated non-melanoma skin cancer - No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy Chemotherapy - No more than 2 prior chemotherapy regimens - One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for recurrent disease are considered 2 regimens - At least 4 weeks since prior chemotherapy - No prior docetaxel - No prior carboplatin - No other concurrent chemotherapy Endocrine therapy - At least 4 weeks since prior hormonal therapy Radiotherapy - See Chemotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - At least 3 weeks since prior major surgery |
| 27 | NCT00086281 | completed | 1 | phase 4 | ['obstructive sleep apnea syndrome'] | ["['G47.33']"] | ['xyrem (x)', 'zolpidem (z)', 'modafinil (m)', 'placebo (p)'] | ['[Na+].OCCCC([O-])=O', 'CN(C)C(=O)CC1=C(N=C2C=CC(C)=CN12)C1=CC=C(C)C=C1', 'CSCC[C@H](N)C(O)=O', 'OC(=O)[C@@H]1CCCN1'] | Inclusion Criteria: - Signed and dated an informed consent prior to beginning protocol required procedures. - Willing and able to complete the entire trial as per the protocol including 6 nights in the sleep lab. - 18 years of age or older. - Have a history of obstructive sleep apnea syndrome (as per American Academy of Sleep Medicine [AASM] Task Force 1999). - Apnea-Hypopnea Index(AHI): 10 to 40 inclusive, lowest O2 saturation ≥75% (see AASM Task Force 1999 criteria) - Females may be included who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial. - In the opinion of the investigator have adequate support for the duration of the trial to include transportation to and from the trial site. In addition, if in the investigator's assessment it is clinically indicated, the patient is willing to not operate a car or heavy machinery for the duration of the trial or for as long as the investigator deems clinically indicated. Exclusion Criteria: - Have taken sodium oxybate (GHB) in the last 30 days. - Have taken any investigational therapy within the 30-day period prior to the initial screening visit for this trial. - Are routinely taking any stimulant medications, sedative hypnotics, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the study. Patients taking anticonvulsants are not eligible to participate even if they are willing to washout anticonvulsants for the trial. - Regularly consume alcohol and are unwilling or unable to totally abstain from alcohol use for the trial duration. - Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol. - Have psychiatric disorders, major affective or psychotic disorders, or other problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms. - Have a current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by the DSM-IV. - Have a serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal), or elevated serum bilirubin (more than 1.5 times the upper limit of normal), or pre-trial ECG results demonstrating clinically significant arrhythmias, greater than a first degree AV block or a history of myocardial infarction within the last six months. - Have an occupation that requires variable shift work or routine night shift. - Have a clinically significant history of seizure disorder either past or present, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past invasive intracranial surgery, and are taking anticonvulsant medications. | |
| 28 | NCT00087334 | terminated | withdrawn due to poor/low accrual | 0 | phase 1/phase 2 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['capecitabine', 'gefitinib', 'oxaliplatin'] | ['CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed* colorectal cancer - Metastatic disease - The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is not required for recurrent metastatic disease unless an interval of > 5 years has elapsed between the initial primary surgery and the development of metastases - Measurable disease - At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic - AST and ALT ≤ 3 times upper limit of normal (ULN) - Bilirubin ≤ ULN - No unstable or uncompensated hepatic disease Renal - Creatinine < 1.5 times ULN OR - Creatinine clearance > 60 mL/min - No unstable or uncompensated renal disease Cardiovascular - No unstable or uncompensated cardiac disease Pulmonary - No evidence of clinically active interstitial lung disease - Asymptomatic patients with chronic stable radiographic changes are eligible - No unstable or uncompensated respiratory disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No known hypersensitivity to gefitinib or any of its excipients - No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine - No severe or uncontrolled systemic disease - Able to receive oral medication - No known dihydropyrimidine dehydrogenase (DPD) deficiency - No known peripheral neuropathy ≥ grade 1 - Absence of deep tendon reflexes as the sole neurological abnormality allowed - No other significant clinical disorder or laboratory finding that would preclude study participation - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I) - No prior chemotherapy for metastatic disease (phase II) - Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease - No prior irinotecan and oxaliplatin (phase II) Endocrine therapy - Not specified Radiotherapy - No concurrent radiotherapy for colorectal cancer Surgery - See Disease Characteristics - More than 4 weeks since prior major surgery (e.g., laparotomy) Other - Recovered from all prior therapy (no unresolved chronic toxicity > grade 2) - More than 4 weeks since prior investigational drugs - No prior epidermal growth factor receptor inhibitor therapy (phase II) - No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort) - No other concurrent investigational drugs - No other concurrent systemic therapy for colorectal cancer |
| 29 | NCT00087646 | completed | 1 | phase 4 | ['hepatitis c, chronic'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['ribavirin', 'ribavirin', 'peginterferon alfa-2a [pegasys]', 'peginterferon alfa-2a [pegasys]', 'peginterferon alfa-2a [pegasys]', 'peginterferon alfa-2a [pegasys]'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - adult patients >=18 years of age; - CHC infection; - liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection; - use of 2 forms of contraception during study and 6 months after the study in both men and women; - Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks. Exclusion Criteria: - women who are pregnant or breastfeeding; - male partners of women who are pregnant; - conditions associated with decompensated liver disease; - other forms of liver disease, including liver cancer; - human immunodeficiency virus infection. | |
| 30 | NCT00091611 | terminated | this study was terminated due to low accrual. | 0 | phase 1 | ['kidney neoplasms'] | ["['D17.71', 'D30.00', 'D30.01', 'D30.02', 'D41.00', 'D41.01', 'D41.02']"] | ['il-2 (interleukin-2)', 'okt3', 'cyclophosphamide', 'fludarabine', 'mesna'] | ['COC1=CC2=C(C=C1)N=C(N2)S(=O)CC1=NC=C(C)C(OC)=C1C', '[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'ClCCN(CCCl)P1(=O)NCCCO1', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | - INCLUSION CRITERIA: CELL HARVEST: - Patients must have metastatic renal cell cancer. - age greater than or equal to 18 years. - Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 at entry to the trial. - Life expectancy of greater than three months. - Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are human immunodeficiency virus (HIV) seropositive can have decreased immune competence and can thus be less responsive to the experimental treatment and more susceptible to it's toxicities.) - Seronegative for hepatitis B antigen. - Seropositive for Epstein-Barr Virus (EBV). - Patients with electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia or arrythmias or age greater than 50 years must have a normal stress cardiac test (stress thallium, stress multi-gated acquisition scan (MUGA), dobutamine echocardiogram or other stress test). - Patients who have a recent prolonged history of cigarette smoking or symptoms of respiratory dysfunction must have pulmonary function testing with an forced expiratory volume in 1 second (FEV(1)) greater than 60% predicted. EXCLUSION CRITERIA: CELL HARVEST: -Active systemic infections, coagulation disorders, contra-indications to receiving interleukin-2 (IL-2) or major medical illnesses of the cardiovascular, respiratory or immune system. INCLUSION CRITERIA: CELL INFUSION: - Patients must have measurable metastatic renal cell cancer and have tumor progression after therapy with interleukin-2 (IL-2). - Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 at entry to the treatment phase of this trial. - Platelet count greater than 100,000/mm^3. - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three times the upper limit of normal. - Serum creatinine less than or equal to 1.6 mg/dl. - Total bilirubin less than or equal to 1.6 mg/dl or direct bilirubin less than or equal to 0.5 mg/dl. - Life expectancy of greater than three months. - At the time of T-cell transfer, the patient must have a T-cell population which has met the attached Certificate of Analysis for tumor recognition and safety testing. - Any patient receiving interleukin-2 (IL-2) must sign a durable power of attorney. - Male and Female patients must be willing to practice contraception during the treatment phase of this study.. - Patients with asymptomatic brain metastases may be considered eligible. EXCLUSION CRITERIA: CELL INFUSION: - Potentially effective therapy for renal cell cancer (RCC) within four weeks of the time the patient receives T-cell transfer (with the exception of local irradiation to non-evaluated sites). - Requirement for steroid therapy. - Active systemic infections, coagulation disorders, contra-indications to receiving interleukin-2 (IL-2) or major medical illnesses or the cardiovascular, respiratory or immune system. - Pregnant patients and nursing mothers will be excluded because of the unknown effects of this therapy on the fetus or nursing infant. |
| 31 | NCT00096304 | terminated | low accrual | 0 | phase 1 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['docetaxel', 'epirubicin hydrochloride'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Meets 1 of the following criteria: - Measurable disease with any prostate-specific antigen (PSA) value - Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - Histologic confirmation required if measurable disease is confined to a solitary lesion - Non-measurable disease with PSA ≥ 5 ng/mL* - The following are considered non-measurable disease: - Bone lesions - Pleural or pericardial effusion - Ascites - CNS lesions - Leptomeningeal disease - Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: *Patients with PSA ≥ 5 ng/mL only are not eligible - Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria: - Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions - One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL - Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart) - Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy - Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Meets 1 of the following criteria: - AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN) - AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN - AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal - Bilirubin normal Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No uncontrolled high blood pressure - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction within the past 6 months - No serious uncontrolled cardiac arrhythmia - No New York Heart Association class III or IV heart disease Other - Fertile patients must use effective contraception during and for at least 3 months after study participation - No peripheral neuropathy ≥ grade 2 - No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - No prior chemotherapy, including estramustine or suramin for prostate cancer - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior antiandrogen therapy - No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - No concurrent palliative radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior surgery and recovered |
| 32 | NCT00100971 | terminated | protocol is withdrawn due to inadequate accrual | 0 | phase 1 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['autologous tumor cell vaccine', 'therapeutic autologous dendritic cells'] | ['[O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O'] | DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy - Newly diagnosed - Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood - No clinical evidence of CNS leukemia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No clinically significant autoimmune disease - No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 months since prior immunotherapy Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified |
| 33 | NCT00102635 | terminated | slow accrual. | 0 | phase 1 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['fenretinide (4-hpr)', 'sch66336'] | ['C\\C(\\C=C\\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(=O)NC1=CC=C(O)C=C1', 'NC(=O)N1CCC(CC(=O)N2CCC(CC2)[C@H]2C3=C(CCC4=C2C(Br)=CC(Cl)=C4)C=C(Br)C=N3)CC1'] | Inclusion Criteria: - Patient has histologically proven squamous cell carcinoma of the head and neck which is biopsy accessible and is not considered curable by standard measures. - Patient has a Karnofsky performance status >/= 70% - Patient has adequate bone marrow function: *WBC >/= 3,000 cells/mm^3, *ANC >/= 1,500 cells/mm^3, *platelet count >/= 100,000 cells/mm^3, *Hgb >/= 9.0 g/dL. - Patient has adequate liver function: *total bilirubin level </= 2.0 mg/dL, *albumin >/= 2.5 g/dL. - Transaminases (SGOT and/or SGPT) may be up to 2.5 x ULN if alkaline phosphatase is </= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are </= ULN. - Patient has adequate renal function: a serum creatinine < 2 mg/dl - Patient has signed a written informed consent. - Patient has received no more than 2 prior chemotherapeutic regimens for recurrent or metastatic disease. Prior biologic therapy is not included. Exclusion Criteria: - Patient has received 3 or more prior chemotherapeutic regimens for recurrent/metastatic disease. - No biopsy accessible tissue. - Patient has received radiation therapy within the past 6 months. - Prior radiation to the biopsy site. - Patient has signs or symptoms of acute infection requiring systemic therapy. - Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent. - Patient has grade 3 or 4 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause. - Patient requires total parenteral nutrition with lipids. - Surgery is anticipated to leave patient unable to swallow the SCH66336 or 4-HPR daily. - Patient has a history of uncontrolled heart disease (including arrhythmia, angina, congestive heart failure, or any heart condition that cannot be controlled with regular ongoing medication) - Because of the known teratogenic effect of retinoids, pregnant women and women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study. - Serious infection or other intercurrent illness requiring immediate therapy. - Inability to swallow oral medications, or other medical or social factors interfering with compliance. - Patients may not take high dose synthetic or natural Vitamin A derivatives (>10,000 IU per day). Patients may not be taking high-dose vitamin A within 30 days of study entry. - Patients should not take any anti-oxidants such as Vitamin E or Vitamin C - Patients with pre-existing retinopathy |
| 34 | NCT00107653 | completed | 1 | phase 4 | ['hepatitis c, chronic'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['ribavirin', 'peginterferon alfa-2a', 'ribavirin', 'peginterferon alfa-2a'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - adult patients 18-65 years of age - chronic hepatitis C , genotype 1 - serologic evidence of CHC infection by an antibody test - chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months - compensated liver disease - use of 2 forms of contraception during the study in both men and women Exclusion Criteria: - previous interferon or ribavirin therapy - systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study - medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure) - decompensated liver disease - women who are pregnant or breastfeeding | |
| 35 | NCT00108355 | completed | 1 | phase 4 | ['ascites', 'cirrhosis'] | ["['R18.0', 'R18.8', 'K70.10', 'K70.11', 'K70.30', 'K70.31', 'K71.50']", "['K74.3', 'K74.4', 'K74.5', 'K74.60', 'K74.69', 'P78.81', 'K70.30']"] | ['albumin', 'intravenous saline infusion (albumin placebo)', 'midodrine', 'oral tablet (midodrine placebo)', 'octreotide lar', 'saline injection (octreotide lar placebo)'] | ['CC1=CC(O)=CC(C)=C1Cl', '[Na+].[Cl-]', 'COC1=CC(C(O)CNC(=O)CN)=C(OC)C=C1', '[H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O', '[Na+].[Cl-]'] | Inclusion Criteria: - Cirrhosis of any etiology - Age 18-80 years - Moderate to severe ascites Exclusion Criteria: - No or small ascites - Severe hepatic hydrothorax - Recent GI (gastrointestinal) hemorrhage - Active bacterial infection - Cardiac failure - Organic renal disease - Hepatocellular carcinoma - Severe comorbidity (advanced neoplasia) - Serum creatinine > 3 mg/dl - Pregnancy | |
| 36 | NCT00110890 | completed | 1 | phase 4 | ['end stage renal disease'] | ["['N18.6', 'I12.0', 'I13.11', 'I13.2']"] | ['cinacalcet'] | ['C[C@@H](NCCCC1=CC(=CC=C1)C(F)(F)F)C1=CC=CC2=CC=CC=C12'] | Inclusion Criteria: - ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month - The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L) - The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L) Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Have had a parathyroidectomy in the 6 months before day 1 - Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1. - Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1 - Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) - Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets | |
| 37 | NCT00112619 | terminated | slow accrual and company withdrawing support to supply the drug | 0 | phase 1 | ['brain and central nervous system tumors', 'carcinoma of unknown primary', 'leukemia', 'lymphoma', 'unspecified childhood solid tumor, protocol specific'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['topotecan hydrochloride'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Diagnosis of neoplastic meningitis secondary to leukemia, lymphoma (including AIDS-related lymphoma), or solid tumor (including primary CNS tumors or carcinomas of unknown primary site), defined by 1 of the following criteria: - Cerebral spinal fluid (CSF) cell count > 5/μL AND evidence of blast cells on cytospin or by cytology (for patients with leukemia or lymphoma) - Presence of tumor cells on cytospin or cytology OR unequivocal presence of meningeal disease by MRI (for patients with solid tumor) - No conventional therapy for neoplastic meningitis exists - Patients with CNS leukemia or lymphoma must be refractory to conventional therapy, including radiotherapy (i.e., second or greater relapse) - Patients with CNS leukemia or lymphoma must have had a negative bone marrow aspiration within the past 2 weeks - No clinical evidence of obstructive hydrocephalus - No compartmentalization of CSF flow by radioisotope indium In 111 or technetium Tc 99 DTPA flow study - No ventriculoperitoneal or ventriculoatrial shunt unless patient is completely shunt-independent - No impending spinal cord compression or other CNS involvement (e.g., acute visual loss secondary to optic nerve involvement) requiring emergent local radiotherapy PATIENT CHARACTERISTICS: Age - 3 to 21 Performance status - Lansky 60-100% (≤ 16 years of age) OR - Karnofsky 60-100% (> 16 years of age) Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Calcium ≥ 7 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Sodium 125-150 mmol/L - Magnesium ≥ 0.7 mmol/L - Must have or be willing to have an intraventricular access device (i.e., Ommaya reservoir) - No uncontrolled infection - HIV-positive patients with AIDS-related lymphomatous meningitis are eligible - No other significant uncontrolled systemic medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior biologic therapy or immunotherapy Chemotherapy - Recovered from prior chemotherapy - At least 1 week since prior intra-colony stimulating factory (CSF) chemotherapy (2 weeks for liposomal cytarabine) - At least 3 weeks since prior systemic chemotherapy for leptomeningeal disease - Concurrent systemic chemotherapy to control systemic disease or bulk CNS disease allowed provided the systemic chemotherapy is not an investigational agent OR any of the following: - High-dose (> 1 g/m^2) methotrexate - High-dose (> 1 g/m^2) cytarabine - Fluorouracil - Capecitabine - Thiotepa - Nitrosoureas - Topotecan Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 8 weeks since prior craniospinal radiotherapy and recovered - No concurrent CNS radiotherapy - Concurrent radiotherapy to extra-CNS sites (e.g., painful bone metastases not in the craniospinal axis) allowed Surgery - Not specified Other - More than 2 weeks since prior and no other concurrent investigational agents - No other concurrent intra-CSF or systemic therapy for leptomeningeal disease |
| 38 | NCT00113295 | completed | 1 | phase 4 | ['anxiety disorder'] | ["['F41.1', 'F41.9', 'F40.9', 'F43.22', 'F41.0', 'F93.0', 'F12.980']"] | ['continued paroxetine cr', 'quetiapine', 'placebo'] | ['OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12', 'FC1=CC=C(C=C1)[C@@H]1CCNC[C@H]1COC1=CC2=C(OCO2)C=C1'] | Inclusion Criteria: - Male and female outpatients, age 18-72. - Primary diagnosis of generalized anxiety disorder. - Patients on concurrent benzodiazepines will be entered into the trial if they remain symptomatic despite stable doses for at least one month Exclusion Criteria: - Pregnant or lactating women or other women of child bearing potential not using acceptable means of birth control - Patients with a primary diagnosis of major depression, dysthymia, panic disorder or social phobia. - Patients with current or history of bipolar disorder, schizophrenia or other psychotic conditions - Patients with post-traumatic stress disorder or obsessive-compulsive disorder current in the past 6 months. - Patients with a history of alcohol or substance abuse or dependence within the last six months. - Patients with significant unstable medical illness. - Ongoing psychotherapy directed toward the treatment of generalized anxiety disorder. - History of hypersensitivity to paroxetine CR, paroxetine or quetiapine. - History of cataracts. - Concurrent use of psychotropic medications including buspirone and antidepressants. Patients must have discontinued buspirone or antidepressant therapy at least two weeks prior to study entry, and fluoxetine at least four weeks prior, but no patient will be taken off effective medication. - Concomitant use of herbs and dietary supplements with known psychotropic properties, including St John's Wort, Kava, Valerian, Gingko, Ginseng, ephedra and weight loss supplements. Other than such agents with known psychotropic properties, no over the counter medications are exclusionary. | |
| 39 | NCT00113529 | completed | 0 | phase 1/phase 2 | ['carcinoma, renal cell'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['gefitinib + sunitinib'] | ['COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | Inclusion Criteria: - Histologically confirmed renal cell carcinoma with metastases - Evidence of unidimensionally measurable disease - Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC Exclusion Criteria: - RCC without any clear (conventional) cell component - History of or known brain metastases - Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry | |
| 40 | NCT00113919 | terminated | due to poor accrual | 0 | phase 1/phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['busulfan'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Patients must have symptomatic multiple myeloma requiring treatment - Patients must have been approved for single or tandem autologous transplant - Patients must be > or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine > 3 mg/dl or a creatinine clearance < 30 ml/minute - Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted, - Patients must have an ECHO or MUGA performed within 60 days prior to registration, LVEF > 40%. - Bilirubin, SGOT, SGPT must be less than 1.5 times the upper limit of normal - Patients must have evaluable myeloma marker for response such as: *Serum M protein >1g/dl or urine M protein >1g/24 hours and/or; *Bone marrow plasmacytosis with >20% plasma cells and/or; *Extramedullary plasmacytosis; *MRI/PET scan has focal lesions due to myeloma. - Patients must be able to receive full doses of DT-PACE, in the opinion of the treating investigator, with the exception of cisplatin. - Patients must have a performance status of 0-2 based on SWOG criteria unless the patient's status is due to active myeloma - All patients must be informed of the investigational nature of the study and have signed an IRB-approved informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: - Serum transaminases > 1.5 x ULN and direct bilirubin > 1.5 mg/dl - HIV positive or active Hepatitis B or Hepatitis C infection; (if serology is positive a quantitative PCR will be done). - Patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. Patients must not currently be receiving therapy for the prior malignancy. - Pregnant or nursing women. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. |
| 41 | NCT00115063 | terminated | ethical issues of continuing control group without treatment | 1 | phase 4 | ['obesity'] | ["['E66.8', 'E66.9', 'E66.1', 'O99.214', 'O99.215', 'O99.210', 'O99.211']"] | ['sibutramine, orlistat, diethylpropion'] | ['CCCCCCCCCCC[C@@H](C[C@@H]1OC(=O)[C@H]1CCCCCC)OC(=O)[C@H](CC(C)C)NC=O'] | Inclusion Criteria: - Participant in the Exclusive Provider Organization (EPO), Managed Care Organization (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State Employees Group Benefits Health Insurance - Agree to travel for treatment to the assigned study site - Agree to randomized treatment assignment - Male and females age 20-60 years - Body Mass Index >40kg/m2 but < 60 kg/m2 - Females must be non-pregnant and using an approved contraception method - Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless waived by Principal Investigator (PI) - Uric Acid <9.0 mg/dl - Normal Creatinine - Normal Thyroid Stimulating Hormone (TSH) - Negative urine pregnancy test for women of childbearing potential - Able to give written informed consent - Able to comply with study procedures Exclusion Criteria: Factors that may limit adherence to interventions or affect conduct of the trial: - Unable or unwilling to give informed consent or communicate with local study staff - Hospitalization for psychiatric illness or substance use/abuse within the past year - Self-report of alcohol or substance abuse within the past twelve months - Current major depressive episode or history of suicidal behaviors - Endorsement of significant recent suicidal ideation (as determined by PI) - Travel plans that do not permit participation - History of prior bariatric surgery, small bowel resection, or extensive bowel resection - Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic medication, herbal medications for weight loss or any medication not approved by the PI. - Another member of the household is a participant or staff member in the study - History of eating disorder such as anorexia nervosa, bulimia, or binge eating - Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder (as determined by the PI) - Currently pregnant or nursing or plans to become pregnant in the next five years - Except for non-melanoma skin cancer, cancer requiring treatment in the past five years, unless the prognosis is excellent - Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active tuberculosis - Cardiovascular disease event within the past year - Severe congestive heart failure (New York Heart Association [NYHA] Functional Class III, IV) - Second degree or greater heart block - Blood Pressure >160 systolic or >100 diastolic on two consecutive visits, unless treated and re-screened - Based upon responses to psychological screening or an interview, patients may be excluded by the study psychologist. - Other medical, psychiatric, or behavioral limitations that in the judgment of the investigator may interfere with study participation or the ability to follow the intervention protocol. - Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or oophorectomy must have a negative urine pregnancy test result at screening. Women of childbearing potential will be allowed to participate if they have undergone tubal ligation, or use one of the following types of contraception: properly used condom or diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual abstinence may constitute an acceptable birth control method for this study with investigator approval. Women with male partners who have had a successful vasectomy (more than one year of unprotected sexual intercourse without pregnancy) are not required to use additional birth control methods as long as the relationship remains exclusive, and the woman agrees to use an approved contraception method with any other male partner. Questions regarding individual patient contraceptive practices should be directed to the Principal Investigator. |
| 42 | NCT00116844 | completed | 1 | phase 4 | ['infections, herpesviridae'] | ["['K94.02', 'K94.12', 'K94.22', 'K94.32', 'N99.511', 'A02.9', 'A31.0']"] | ['valaciclovir', 'placebo'] | ['CC(C)[C@H](N)C(=O)OCCOCN1C=NC2=C1NC(N)=NC2=O'] | Inclusion Criteria: - In overall general good health. - HSV-2 (Herpes Simplex Virus-2) seropositive at screening. Exclusion criteria: - have active lesions consistent with genital herpes. - previous history of symptomatic genital herpes. - history of recurrent, undiagnosed symptoms consistent with genital herpes. | |
| 43 | NCT00118378 | completed | 1 | phase 4 | ['hiv infections', 'fatigue'] | ["['Z21']", "['R53.83', 'G93.3', 'R53.82', 'R53.0', 'T67.6XXS', 'T67.6XXA', 'T67.6XXD']"] | ['modafinil', 'placebo'] | ['NC(=O)C[S@@](=O)C(C1=CC=CC=C1)C1=CC=CC=C1'] | Inclusion Criteria: 1. Ages 18-75 2. HIV+ 3. Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale) 4. Fatigue duration for 3+ months 5. English-speaking 6. Able to give informed consent 7. Fecund women uses barrier method of contraception Exclusion Criteria: 1. Primary care doctor does not approve of study participation 2. Unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic infection [O.I.] in past month) 3. Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range) 4. Untreated hypothyroidism (thyroid stimulating hormone [TSH] over 5 IUI/mL) 5. Untreated and uncontrolled hypertension 6. Clinically significant anemia (hematocrit <30%) 7. Started testosterone or nandrolone in past 6 weeks 8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months 9. Untreated or under-treated major depressive disorder 10. Started antidepressant medication within past 6 weeks 11. Substance abuse/dependence (past 4 months) 12. Regular and frequent cannabis use (> twice/week regularly) 13. Currently clinically significant suicidal ideation or Hamilton Depression Rating Scale (HAM-D) >24 14. History or current psychosis or bipolar disorder 15. Pregnant or breastfeeding 16. Significant untreated insomnia (score >3 on HAM-D insomnia items) 17. Currently taking psychostimulant medication or past nonresponse to modafinil 18. Has no alternative viable antiretroviral regimen after the current one 19. Left ventricular hypertrophy; mitral valve prolapse | |
| 44 | NCT00118430 | completed | 1 | phase 4 | ['pain', 'depression'] | ["['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']", "['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['antidepressants', 'usual care'] | ['CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', '[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC'] | Inclusion Criteria: - Moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry - History of or current use of at least one medication for pain - English-speaking Exclusion Criteria: - Moderate to severe cognitive impairment - Schizophrenia or other psychotic disorders - Receiving disability benefits for pain - Anticipated life expectancy less than 12 months - Pregnancy | |
| 45 | NCT00118716 | completed | 1 | phase 4 | ['bronchospasm', 'activity/exercise induced bronchospasm'] | ["['J98.01', 'J45.990']", "['Y93.A3', 'Y93.A9', 'Y93.14', 'Y93.A1', 'Y93.B1', 'Y93.B9']"] | ['fluticasone propionate/salmeterol', 'fluticasone propionate'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', 'COC1=CC=CC(=C1)N=C1C(=CNC2=C1C=C(C=C2C)S(=O)(=O)C1=CC=CC(=C1)C(=O)N(C)C)C(O)=N'] | Inclusion criteria: - Diagnosed with persistent asthma for 3 months or longer. - Experienced worsened asthma symptoms during physical activity. - Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril). Exclusion criteria: - Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months. - Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma. - Admitted to a hospital within the previous 6 months due to asthma symptoms. - Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.) - The study physician will evaluate other medical criteria. | |
| 46 | NCT00118742 | completed | 1 | phase 4 | ['liver transplantation'] | ["['Z52.6', 'K71.8', 'K71.7', 'A06.4', 'C22.0', 'C22.3', 'K70.0']"] | ['mycophenolate mofetil [cellcept]', 'tacrolimus', 'cyclosporine', 'sirolimus'] | ['COC1=C(C\\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'CO[C@@H]1C[C@@H](CC[C@H]1O)\\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC'] | Inclusion Criteria: - Adult patients 18-74 years of age - Single primary liver transplant from a deceased donor - CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours) - Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C. Exclusion Criteria: - Liver allograft from a living donor or a split liver - Multiple organ transplant - Dialysis therapy for >14 days from transplantation to randomization - History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer) - Previous sirolimus therapy | |
| 47 | NCT00119158 | completed | 1 | phase 4 | ['atopic dermatitis'] | ["['L20.89', 'L20.9']"] | ['combination of pimecrolimus and fluticasone', 'pimecrolimus'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', '[H][C@]1(CC[C@H](Cl)[C@@H](C1)OC)\\C=C(/C)[C@@]1([H])OC(=O)[C@]2([H])CCCCN2C(=O)C(=O)[C@]2(O)O[C@@]([H])([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC)C(=O)C[C@H](O)[C@H]1C)OC'] | Inclusion Criteria: - Age 2 to 65 years - Clinical diagnosis of (Atopic Dermatitis) AD according to the American Academy of Dermatology (AAD) Consensus Conference (2001) - At least two lesions of AD on symmetrical part of the body (same location for each side of the body), of severe intensity (m-EASI is at least 7 on each site, with erythema of at least 3 (severe) and papulation/infiltration of at least 3 (severe)) and similar severity (m-EASI does not differ from more than 2 points on both sides) - Signed written informed consent - Willingness and ability to comply with the study requirements - Female is able to enter and participate in this study if she is of: - Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or - Childbearing potential, has a negative pregnancy test (urine) at the screen visit and agrees to an adequate method of birth control throughout the study (which may, at the investigator's discretion, include abstinence) Exclusion Criteria: - History of immune deficiencies or history of malignant disease - Patients with moderate to severe lichenification at the target areas (i.e. score 2 or 3) - Active cutaneous bacterial, viral or fungal infections in target areas - History of other skin disorders, including Netherton syndrome, that could interfere with the evaluations - Use of any topical treatment known or suspected to have an effect on atopic dermatitis within one week prior to the screen visit (except for calcineurin inhibitors, for which the washout is 2 weeks) - Use of any systemic treatment (including phototherapy) known or suspected to have an effect on AD within four weeks prior to the screen visit [(patients on a stable and low dose of inhaled steroids, on a stable dose of anti histamines, on stable dose of leukotriene antagonists, or receiving occasional short-acting b2-agonists for the treatment of asthma and topical corticosteroids (nasal spray) for the treatment of allergic rhinitis may participate). High-dose inhaled corticosteroids (> 440 mcg of fluticasone a day) and anti-IgE products are not permitted]. - Known sensitivity to pimecrolimus or vehicle (placebo) or fluticasone propionate cream or any of their ingredients - Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study - Use of any other investigational agent in the last 30 days | |
| 48 | NCT00121719 | completed | 1 | phase 1 | ['solid tumor or lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['lenvatinib'] | ['COC1=C(C=C2C(OC3=CC(Cl)=C(NC(O)=NC4CC4)C=C3)=CC=NC2=C1)C(O)=N'] | INCLUSION CRITERIA: Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study: 1. Patients with histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available. 2. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved. 3. Aged greater than or equal to 18 years. 4. Karnofsky performance status greater than or equal 70%. 5. Written informed consent to participate in the study. EXCLUSION CRITERIA: Patients with the following characteristics will not be eligible for the study: 1. Brain tumors or brain or leptomeningeal metastases. 2. Any of the following laboratory parameters: 1. hemoglobin less than 9 g/dl (5.6 mmol/L) 2. neutrophils less than 1.5 x 10^9/L 3. platelets less than 100 x 10^9/L 4. serum bilirubin greater than 25 micro-mol/l (1.5 mg/dl) 5. other liver parameters greater than 3 x the upper limit of normal (ULN) 6. serum creatinine greater than 1.5 x ULN or creatinine clearance less than 60 ml/minute 3. Uncontrolled infections. 4. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start. 5. Any treatment with investigational drugs within 30 days before the start of the study. 6. Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients of childbearing potential must use adequate contraceptive protection, defined as two forms of contraception, one of which must be a barrier method. 7. Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection. 8. History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance. 9. Legal incapacity. 10. Centrally located or squamous cell carcinoma of the lung. 11. Proteinuria greater than 1+ on bedside testing. 12. History of gastrointestinal malabsorption. 13. Surgery involving gastro- and/or intestinal anastomosis within four weeks of study start. 14. Patients with bleeding or thrombotic disorders. 15. Patients using therapeutic dosages of anticoagulants. 16. Poorly controlled hypertension (defined as a change in hypertensive therapy within three months of study start) or patients diagnosed with hypertension (defined as a repeat blood pressure measurement of 160/90 mmHg or higher) at screening. | |
| 49 | NCT00121810 | completed | 1 | phase 4 | ['kidney transplantation'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['mycophenolate mofetil [cellcept]', 'corticosteroids', 'calcineurin inhibitors', 'sirolimus'] | ['COC1=C(C\\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C', 'CO[C@@H]1C[C@@H](CC[C@H]1O)\\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC'] | Inclusion Criteria: - Adult patients 18-75 years of age - Kidney transplant 30-180 days post-transplantation - Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry - No known contraindications to sirolimus Exclusion Criteria: - Multiple organ transplant recipients or secondary kidney transplant recipients - Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry - More than 1 biopsy-proven episode of acute rejection prior to study entry - Treated with sirolimus before the study - Organ transplant or expected organ transplant, other than kidney - History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer) | |
| 50 | NCT00123162 | completed | 1 | phase 1/phase 2 | ['dysmenorrhea'] | ["['N94.4', 'N94.5', 'N94.6']"] | ['sildenafil citrate', 'placebo'] | ['CCCC1=NN(C)C2=C1NC(=NC2=O)C1=C(OCC)C=CC(=C1)S(=O)(=O)N1CCN(C)CC1'] | Inclusion Criteria: - Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of >35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe. Exclusion Criteria: - Secondary dysmenorrhea - Any current medication - Serious medical condition | |
| 51 | NCT00124943 | completed | 0 | phase 1/phase 2 | ['coronary restenosis'] | ["['I25.84', 'I25.41', 'I25.42', 'Z98.61', 'Q24.5', 'T46.3X6S', 'I25.82']"] | ['nanoparticle paclitaxel'] | ['[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C'] | Inclusion Criteria: - Male or non-pregnant and non-lactating female, and ≥ 18 years of age. - Diagnosis of angina pectoris or unstable angina pectoris or patients with documented silent ischemia. - Left ventricular ejection fraction ≥30% - Patient has undergone successful and uncomplicated stenting of up to 2 de novo lesions in native coronary arteries OR patient has undergone successful and uncomplicated balloon angioplasty of up to 2 in-stent restenosis (ISR) lesions in native coronary arteries, but not both. - Thrombolysis In Myocardial Infarction (TIMI) 3 coronary flow post-stenting for de novo lesions or post balloon angioplasty for ISR lesions. - No angiographic evidence of thrombus post-procedure. - Target vessel ≥2.5 mm diameter (by angiography). - Each de novo lesion is such that it is stented with ≤ 25 mm of single continuous stent. - Each in-stent restenosis (ISR) lesion is ≤ 25 mm in length. - There is at least 5 mm of non-diseased vessel on either side of target lesion(s). - By intravascular ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 2.5 mm or an in-stent luminal area ≥ 5.0 mm^2 - Patient or guardian has provided a signed written informed consent to participate in the study and in all follow-up assessments using a form that is approved by the local Institutional Review Board (IRB)/Ethics Committee of the investigative site. Exclusion Criteria: - Target de novo lesion was treated with a drug-eluting stent - Target ISR lesion requires any treatment other than balloon angioplasty - Patient has both a de novo lesion and an ISR lesion. - If more than 2 lesions are treated with percutaneous coronary intervention (PCI), or it is anticipated that additional lesions will require treatment within 2 months. - Previous PCI within preceding two months. - Intended surgical intervention within 6 months of enrollment in the study. - Unprotected left main disease with >50% stenosis - Malapposition, dissection, or unmasking of a significant narrowing in the inflow or outflow area of the implanted stent. - Women who are pregnant and women of child bearing potential who do not use adequate contraception - Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational drug or device trial. - Patient has a life expectancy of less than 12 months or there are factors making clinical and/or angiographic follow-up difficult - Any significant medical condition which, in the investigator's opinion, may interfere with the patient's optimal participation in the study - Heart transplant candidate or recipient - Patient is immunosuppressed or is HIV positive. - Patient has experienced a Q wave or a non Q wave myocardial infarction (MI) with documented total creatine kinase (CK) ≥2 times normal within the preceding 24 hours and the CK and creatine kinase-MB fraction (CK-MB) enzymes remain above normal at the time of the procedure. - Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80 mmHg, with no response to fluids or SBP less than 100 mmHg with vasopressors (in absence of bradycardia) - Any individual who may refuse a blood transfusion - Documented major gastro-intestinal bleeding within 3 months - The following lab values at baseline are exclusionary: - Serum creatinine > 2.5 mg/dl; - Platelet count < 150,000 cells/mm^3; - Absolute neutrophil count (ANC) < 2000 cells/mm^3; - Hemoglobin (HGB) <9 g/dl; - Total bilirubin >1.5 mg/dl; - Alanine Aminotransferase (SGPT) > 2.5 x upper limit of normal range (ULN); - Aspartate Aminotransferase (SGOT) > 2.5 x ULN; - Alkaline phosphatase > 2.5 x ULN. - Known allergy/hypersensitivity/contraindication to the study drug; to any taxanes; or to any required study treatment: aspirin, clopidogrel bisulfate, stent materials - Pre-existing peripheral neuropathy of National Cancer Institute (NCI) Toxicity Grade > 1. | |
| 52 | NCT00125593 | completed | 1 | phase 4 | ['kidney disease, chronic'] | ["['I12.9', 'N18.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5', 'I13.0']"] | ['simvastatin 20 mg', 'ezetimibe 10mg', 'placebo'] | ['[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC'] | Inclusion Criteria: - History of chronic kidney disease (CKD): either patients who are pre-dialysis (with a plasma or serum creatinine greater than or equal to 150 micromol/l [greater than or equal to 1.7 mg/dl] in men, or greater than or equal to 130 micromol/l [greater than or equal to 1.5 mg/dl] in women); or patients on dialysis (hemodialysis or peritoneal dialysis) - Men or women aged greater than or equal to 40 years Exclusion Criteria: - Definite history of myocardial infarction or coronary revascularization procedure - Functioning renal transplant, or living donor-related transplant planned - Less than 2 months since presentation as an acute uraemic emergency (but could be entered later, if appropriate) - Definite history of chronic liver disease, or abnormal liver function (i.e. alanine aminotransferase [ALT] greater than 1.5 x upper limit of normal [ULN] or, if ALT not available, aspartate aminotransferase [AST] greater than 1.5 x ULN). (Note: Patients with a history of hepatitis were eligible provided these limits were not exceeded.) - Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) greater than 3 x ULN - Definite previous adverse reaction to a statin or to ezetimibe - Concurrent treatment with a contraindicated drug. (Note: Patients who were temporarily taking such drugs could have been re-screened for participation in the study when they discontinued them, if appropriate.) These contraindicated drugs included: HMG-CoA reductase inhibitor ("statin"); fibric acid derivative ("fibrate"); nicotinic acid; macrolide antibiotic (erythromycin, clarithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease-inhibitors (e.g. antiretroviral drugs for HIV infection); nefazodone; ciclosporin - Child-bearing potential (i.e. premenopausal woman who was not using a reliable method of contraception) - Known to be poorly compliant with clinic visits or prescribed medication - Medical history that might have limited the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse) | |
| 53 | NCT00127712 | completed | 1 | phase 4 | ['atrial fibrillation'] | ["['I48.0', 'I48.21', 'I48.91', 'I48.11', 'I48.19', 'I48.20']"] | ['amiodarone'] | ['CCCCC1=C(C(=O)C2=CC(I)=C(OCCN(CC)CC)C(I)=C2)C2=C(O1)C=CC=C2'] | Inclusion Criteria: - Males or females over the age of 40 - Scheduled to undergo pneumonectomy or lobectomy Exclusion Criteria: - History (hx) of atrial fibrillation - Prior severe side effects from amiodarone - Elevated liver enzymes >3 times the upper limit of normal (UNL) - QTc interval > 450 ms - Receiving class Ia or class III antiarrhythmics | |
| 54 | NCT00129961 | completed | 1 | phase 4 | ['skin neoplasms', 'kidney transplantation'] | ["['C79.2', 'C44.500', 'C44.90', 'D23.9', 'D48.5', 'C44.00', 'C44.301']", "['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['sirolimus', 'cyclosporine or tacrolimus'] | ['CO[C@@H]1C[C@@H](CC[C@H]1O)\\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC', 'CO[C@@H]1C[C@@H](CC[C@H]1O)\\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC'] | Inclusion Criteria: - Kidney transplant at least 1 year prior - Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day. - Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen - History of NMSC within last 3 years Exclusion Criteria: - History of other cancer within last 3 years - NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months - Multiple organ transplant | |
| 55 | NCT00135226 | active, not recruiting | 1 | phase 4 | ['diabetes mellitus'] | ["['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['aspirin', 'omega-3 ethyl esters', 'placebo aspirin', 'placebo omega-3 ethyl esters'] | ['[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl'] | Inclusion Criteria: - Males or females with type 1 or type 2 diabetes mellitus. - Aged ≥ 40 years. - No previous history of vascular disease. - No clear contra-indication to aspirin. - No other predominant life-threatening medical problem. Exclusion Criteria: - Definite history of myocardial infarction, stroke or arterial revascularisation procedure. - Currently prescribed aspirin, warfarin or any other blood thinning medication. | |
| 56 | NCT00137436 | completed | 0 | phase 1/phase 2 | ['prostatic neoplasms'] | ["['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']"] | ['docetaxel', 'prednisone', 'su011248'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C', 'CCN(CC)CCNC(=O)C1=C(C)NC(\\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C'] | Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation - Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: - Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy - Prior chemotherapy - Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis) - History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec - Central Nervous System (CNS) involvement | |
| 57 | NCT00138424 | terminated | 0 | phase 1/phase 2 | ['bk virus (nephropathy)'] | ["['N14.0', 'N15.0', 'A36.84', 'B58.83', 'B52.0', 'N13.71', 'N14.3']"] | ['cidofovir', 'placebo'] | ['NC1=NC(=O)N(C[C@@H](CO)OCP(O)(O)=O)C=C1'] | Inclusion Criteria: - Aged greater than or equal to 18 years. - Kidney or kidney/pancreas transplant recipient. - New onset BK Virus Nephropathy (BKVN) diagnosed by a positive plasma polymerase chain reaction (PCR) assay for BK virus deoxyribonucleic acid (DNA) or by a renal biopsy demonstrating BK virus (by immunohistochemistry, electron microscopy and/or in situ hybridization) obtained as part of standard medical care within 60 days prior to receipt of first dose of study drug. - BK virus load in plasma greater than 10,000 copies/mL within prior 21 days. - Glomerular filtration rate greater than 30 mL/min using Levey calculations. - Absolute neutrophil count greater than 1000/microliter [with granulocyte colony stimulating factor (GCSF) support as necessary]. - Women must be post-menopausal, surgically sterile or willing to use adequate contraception (barrier method with spermicide, intrauterine device, oral contraceptives, implant or other licensed hormone method) from time of study enrollment through 1 month after the last dose of study treatment. Men must be surgically sterile or willing to use contraception (barrier method with spermicide) from time of study enrollment through 3 months after the last dose of study treatment. Exclusion Criteria: - Unable to provide valid informed consent. - History of intolerance to cidofovir or related compounds (i.e. other nucleotide derivatives [adefovir or tenofovir]). - Pregnant or breast feeding women. - Prior treatment with cidofovir within the last 2 weeks. - Receipt of another investigational drug with proven nephrotoxic drug interaction with cidofovir or known antipolyoma virus activity one month prior to study entry. - Contraindication to renal biopsy (e.g., anticoagulant medication, unwilling to undergo biopsy). - Currently receiving or anticipated to receive any of the following within 2 weeks of randomization: - Amphotericin preparation (intravenous) - Aminoglycosides (intravenous) - Platinum - based chemotherapeutic agents - NSAIDs - non steroidal anti-inflammatory drugs (aspirin given for cardioprotective treatment is acceptable up to 650 mg per oral daily) - Foscarnet - Pentamidine (intravenous) - Probenecid - Leflunomide - Hypotony or uveitis. | |
| 58 | NCT00139776 | completed | 1 | phase 4 | ['osteoarthritis, knee', 'osteoarthritis, hip'] | ["['M17.9', 'M17.0', 'M17.10', 'M17.11', 'M17.12', 'M17.2', 'M17.30']", "['M16.9', 'M16.0', 'M16.10', 'M16.11', 'M16.12', 'M16.30', 'M16.31']"] | ['celecoxib', 'celecoxib'] | ['CC1=CC=C(C=C1)C1=CC(=NN1C1=CC=C(C=C1)S(N)(=O)=O)C(F)(F)F', 'CC1=CC=C(C=C1)C1=CC(=NN1C1=CC=C(C=C1)S(N)(=O)=O)C(F)(F)F'] | Inclusion Criteria: - Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone. Exclusion Criteria: - Subject has had surgery on index joint. - Subject has history of rheumatoid arthritis or fibromyalgia syndrome. - Subject has active gastrointestinal or cardiovascular disease. | |
| 59 | NCT00141037 | completed | 0 | phase 1/phase 2 | ['kidney diseases', 'kidney transplantation', 'kidney transplant', 'renal transplantation', 'renal transplant'] | ["['I12.9', 'N18.9', 'Q61.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5']", "['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']", "['T86.11', 'T86.12', 'T86.13', 'Z94.0', 'T86.10', 'T86.19', 'Z48.22']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['daclizumab', 'mycophenolate mofetil (mmf)', 'prednisone', 'tacrolimus', 'ganciclovir', 'valganciclovir', 'trimethoprim and sulfamethoxazole'] | ['COC1=C(C\\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'NC1=NC2=C(N=CN2COC(CO)CO)C(=O)N1', 'CC(C)[C@H](N)C(=O)OCC(CO)OCN1C=NC2=C1NC(N)=NC2=O', 'CC1=CC(NS(=O)(=O)C2=CC=C(N)C=C2)=NO1'] | Inclusion Criteria: - Primary recipient of a kidney transplant - Meets site-specific transplant criteria - Panel Reactive Antibody (PRA) of 20% or less - Willing to use acceptable forms of contraception - Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: - Previous treatment with steroids within 6 months prior to transplantation - Received en-bloc kidney or other kidney that does not meet protocol-specified requirements - Received an organ from an human leukocyte antigen (HLA) identical donor or a non-heart-beating donor - Received a solid organ other than a kidney - Received a bone marrow or hematopoietic stem cell transplant - Received a repeat kidney transplant - Currently receiving an investigational pharmacologic or biologic agent - Human Immunodeficiency virus (HIV) infected or infected with another immunodeficiency virus - Hypersensitivity to murine products or the study drugs or their formulations - Inability to measure height accurately - Pregnant or breastfeeding | |
| 60 | NCT00141102 | completed | 1 | phase 4 | ['osteoarthritis', 'arthritis, rheumatoid'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']", "['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['celecoxib', 'diclofenac + omeprazole'] | ['CC1=CC=C(C=C1)C1=CC(=NN1C1=CC=C(C=C1)S(N)(=O)=O)C(F)(F)F', 'OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl'] | Inclusion Criteria: - Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management - Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit Exclusion Criteria: - Active GD ulceration or GD ulceration within 90 days of the screening visit. - Concomitant use of low dose aspirin - Previous MI, stroke or significant vascular disease. | |
| 61 | NCT00141518 | completed | 1 | phase 4 | ["advanced idiopathic parkinson's disease"] | ["['G20']"] | ['levodopa-carbidopa intestinal gel (lcig)'] | ['C[C@@](CC1=CC(O)=C(O)C=C1)(NN)C(O)=O'] | Inclusion Criteria: - Advanced idiopathic Parkinson's disease Exclusion Criteria: - Other diseases which might influence compliance or participation in the study | |
| 62 | NCT00147537 | completed | 1 | phase 1/phase 2 | ['carcinoma, non-small-cell lung'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['cp-751,871', 'paclitaxel', 'carboplatin', 'cp-751,871', 'paclitaxel', 'carboplatin', 'erlotinib'] | ['CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', 'CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', 'COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2'] | Inclusion Criteria: - Diagnosis of advanced/metastatic lung cancer Exclusion Criteria: - Previous treatment with chemotherapy - Uncontrolled diabetes - History/active cardiovascular disease | |
| 63 | NCT00149227 | completed | 1 | phase 4 | ['hypertension', 'ischemic heart disease', 'congestive heart failure', 'stroke'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']", "['I24.9', 'I25.9', 'I24.8', 'I25.89', 'Z82.49']", "['I50.20', 'I50.21', 'I50.22', 'I50.30', 'I50.31', 'I50.32', 'I50.40']", "['G46.4', 'G46.3', 'Z82.3']"] | ['valsartan', 'non-arb'] | ['CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O'] | Inclusion Criteria: - Clinical diagnosis of hypertension - Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) Exclusion Criteria: - Patients who have already been administered ARB - Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) - Severe/malignant/secondary hypertensive patients - Pregnant women and women of childbearing potential - History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months - Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block - Severe renal impairment (Serum creatinine >3.0 mg/dl) - Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.) | |
| 64 | NCT00162370 | completed | 1 | phase 4 | ['coronary artery disease', 'heart disease'] | ["['I25.10', 'I25.110', 'I25.119', 'I25.111', 'I25.118']", "['I11.0', 'I11.9', 'I27.1', 'I51.9', 'I09.9', 'I27.9', 'I01.8']"] | ['perflutren lipid microsphere injectable suspension'] | ['FC(F)(F)C(F)(F)C(F)(F)F'] | Inclusion Criteria: - Peri or Post menopausal women without symptoms and having risk factors for heart disease or experiencing atypical chest pain - Must be able to perform an exercise stress test Exclusion Criteria: - Previous confirmed heart disease | |
| 65 | NCT00166504 | completed | 1 | phase 4 | ['hypercholesterolemia'] | ["['E78.01', 'E78.00', 'Z83.42']"] | ['ezetimibe (+) simvastatin', 'atorvastatin'] | ['[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC', 'CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1'] | Inclusion Criteria: - Clinical diagnosis of hypercholesterolemia - LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL - National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline Exclusion Criteria: - Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe | |
| 66 | NCT00176241 | terminated | slow accrual | 0 | phase 1 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['gemcitabine', 'paclitaxel'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', 'CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1'] | Inclusion Criteria: 1. 18 yrs old or greater & have histologically or cytologically proven metastatic or recurrent head & neck cancer & have failed at least 1 prior, but not more than 3 chemotherapeutic regimen. Patients who have recurred after previous surgery and/or radiation may participate in this trial, & patients may have had prior neoadjuvant or adjuvant therapy. No restriction is placed on the # of cycles (beyond 1) of prior therapy, however, patients must not have received the combination of Gemcitabine & Paclitaxel previously. 2. Patients with known brain metastases are eligible for this trial if disease has been treated & the patient is clinically stable & documented by a stable or improved pretreatment CT or MRI of the brain to evaluate CNS disease within 28 days prior to registration. 3. Patients must have measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable disease must be assessed within 28 days prior to registration & non-measurable must be assessed within 42 days prior to registration. Pleural effusions, ascites & lab parameters are not acceptable as only evidence of disease. 4. Patients must have progressed after at least 1 prior chemotherapeutic regimen. Prior biologic therapy or radiation is permitted; however, at least 2 wks must have elapsed since completion of prior therapy & patients must have recovered from all associated toxicities at time of registration. 5. At least 3 wks must have elapsed since surgery (thoracic or other major surgeries) & patients must have recovered from all associated toxicities at time of registration. Measurable or non-measurable disease must be present outside the area of surgical resection. 6. Patients must have an ANC 1,500/µl & platelet count 100,000/µl obtained within 28 days prior to registration. 7. Patients must have adequate hepatic function documented by a serum bilirubin 1.5 x institutional ULN & LFTs (SGOT or SGPT) 2.5 x the institutional ULN obtained within 28 days prior to registration. 8. All patients with pulmonary metastasis must have an FEV1 of > 1000 ml/min obtained within 28 days prior to registration & must have PFTs with DLCO. 9. All patients must have a Zubrod Performance Status of 0,1 or 2. 10. Peripheral neuropathy, if present, must be Grade 1. 11. Patients must be informed of investigational nature of this study & must sign & give written informed consent in accordance with institutional & federal guidelines. Exclusion Criteria: 1. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 yrs. 2. Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry & for duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3. Patients taking drugs that are strong inducers of the enzyme CYP3A4 including anticonvulsants (i.e., phenytoin, phenobarbital, carbamazepine, or primidone) & rifampin OR strong inhibitors of CYP3A4 (clarithromycin, itraconazole, and ketoconazole) will be excluded from this study. Patients must be off these medications for 2 wks in order to participate in this trial. |
| 67 | NCT00179010 | terminated | study was terminated because funding could not be secured | 0 | phase 1 | ['ischemia'] | ["['H35.82', 'I67.82', 'I25.6', 'P91.0', 'N28.0', 'P29.4', 'T79.6XXS']"] | ['adenosine', 'adenosine mono phosphate (amp)'] | ['NC1=C2N=CN([C@@H]3O[C@H](CO)[C@@H](O)[C@H]3O)C2=NC=N1', '[H][C@]12SC(C)(C)[C@@H](N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=CC=C1)C(O)=O'] | Inclusion Criteria: - Healthy volunteers - Age 18-65 - Non smokers Exclusion Criteria: - Smokers - Any chronic disease |
| 68 | NCT00179478 | completed | 1 | phase 4 | ['multiple sclerosis', 'optic neuritis', 'transverse myelitis', 'acute brainstem/cerebellar syndrome'] | ["['G35', 'C81.18']", "['H46.8', 'H46.9']", "['G37.3']", "['D68.61', 'D69.41', 'D81.4', 'E24.1', 'E26.01', 'E26.81', 'E34.0']"] | ['interferon beta 1a 30 ug im once weekly'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Previous participation in CHAMPS study - Participation in a study site willing to participate in the CHAMPIONS10 extension study - Willingness to enroll in the CHAMPIONS 10 extension - Willingness to sign informed consent Exclusion Criteria: - Discovery of an alternative neurological disorder other than MS as a cause of initial neurological symptoms - A severe systemic disease with likely mortality within 3 years | |
| 69 | NCT00180713 | completed | 1 | phase 1/phase 2 | ['pulmonary hypertension'] | ["['I27.0', 'I27.20', 'I27.21', 'I27.24', 'I27.29', 'P29.30', 'I27.22']"] | ['simvastatin', 'placebo'] | ['[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC'] | Inclusion Criteria: - Patients with idiopathic PAH or PAH related to collagen vascular disease - Age 18 years or over - Receiving conventional therapy with diuretics, digoxin, warfarin, sildenafil and bosentan. Stable for 1 month - 6 minute walk distance between 150m and 450m - Modified NYHA functional class II or III Exclusion Criteria: - PAH from a cause other than permitted by entry criteria - Change in PAH treatment in past 4 weeks - Patients requiring prostanoid therapy - Patients already taking a statin - Clinically significant disturbance of liver function - AST or ALT >3xULM; bilirubin >1.5xULM - Contraindication for a magnetic resonance scan | |
| 70 | NCT00182078 | completed | 1 | phase 4 | ['posttraumatic stress disorder', 'depression'] | ["['F43.10', 'F43.11', 'F43.12']", "['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['placebo', 'sertraline'] | ['CN[C@H]1CC[C@@H](C2=CC(Cl)=C(Cl)C=C2)C2=CC=CC=C12'] | Inclusion Criteria: - Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn - Between the ages of 6 - 20 years - Recent experience of an acute burn, injury, or surgery meeting the Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion - Child's response to the stressor meets Diagnostic and Statistical Manual(DSM-IV) A2 response criterion - Proficiency in either English or Spanish Exclusion Criteria: - No memory of the injury - Current use of an anti-depressant - Known hypersensitivity to sertraline - Diagnosis of Bipolar Disorder - Diagnosis of PTSD - Mental Retardation - Traumatic Brain Injury - New onset or marked worsening of a seizure disorder | |
| 71 | NCT00186186 | completed | 1 | phase 4 | ['depression, bipolar'] | ["['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['depakote er'] | ['CCCC(CCC)C(O)=O'] | Inclusion Criteria: - Bipolar I, II or NOS currently suffering from depression - Both: both female and male participants are being studied - Adults 18 years and older of any race Exclusion Criteria: - Schizophrenia or schizoaffective disorder and other disorders excluded at the discretion of the investigator's discretion - Substance dependence within the past 3 months and abuse within the past 2 weeks prior to study. - Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding marijuana, as long as dependence and abuse are ruled out according to DSM-IV) - Significant risk harm to self or others based on history and mental status exam - Clinically significant or unstable medical condition - Unstable thyroid pathology and treatment initiated or altered within the past 3 months - Clinically significant abnormal laboratory test results, vital signs, as judged by the investigators - Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are judged to be unreliable in their use of contraception - Subjects who failed (because of inefficacy or adverse effects) an adequate trial of Depakote; eligible patient's may not have received Depakote within 30 days of screen | |
| 72 | NCT00186446 | completed | 1 | phase 4 | ['major depressive disorder', 'nicotine dependence'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']", "['F17.200', 'F17.210', 'F17.208', 'F17.209', 'F17.218', 'F17.219', 'F17.228']"] | ['bupropion and smoking cessation behavioral intervention'] | ['CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1'] | Inclusion Criteria: - Age at least 18 at the beginning of the study - Smoking at least 10 cigarettes a day (1/2 pack) - Meets DSM-IV criteria for major depressive episode Exclusion Criteria: - Currently pregnant - Currently breastfeeding - Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis - History of a seizure, seizure disorder, significant head trauma or central nervous system tumor - Family history of seizures - Currently using intravenous drugs - Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis - Currently using any over-the-counter stimulants and anorectics (diet pills) - Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa - Currently on NRT or bupropion (Zyban) - Current or past diagnosis of anorexia nervosa - Previous allergic response to fluoxetine, bupropion, or NRT - Previous failed quit attempt using NRT and bupropion in combination - Current suicidal ideation - Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence | |
| 73 | NCT00190775 | completed | 1 | phase 4 | ['attention deficit hyperactivity disorder'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['atomoxetine hydrochloride', 'placebo'] | ['CNCC[C@@H](OC1=CC=CC=C1C)C1=CC=CC=C1'] | Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID). - Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or greater Visit 2 and 3. - Adult Men and Women age 18 years or older at time informed consent is obtained. - Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study. - Must have one or more children 6-17 years of age living the home as the primary residence. Exclusion Criteria: - Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder. - Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder. - Taking psychotropic medications on a regular basis. - Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial. - Previously taken an adequate trial of atomoxetine. | |
| 74 | NCT00194025 | completed | 1 | phase 4 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['valproate'] | ['CCCC(CCC)C(O)=O'] | Inclusion Criteria: - Must have a diagnosis of schizophrenia as confirmed by the MINI - Must be on antipsychotic medication - Must be age 50 year or older - Must be capable of providing written informed consent for study participation. In situations where individuals have guardians of person, guardian and subject must both provide written consent; and - Must live in the Northeast Ohio area. Exclusion Criteria: - A primary psychiatric DSM Axis I diagnosis other than schizophrenia - Actively abusing substances; or - Medically unstable. | |
| 75 | NCT00195351 | completed | 1 | phase 4 | ['appendicitis', 'cholecystitis', 'cross infection', 'diverticulitis', 'peritonitis'] | ["['K36', 'K37', 'K35.80', 'K35.20', 'K35.21', 'K35.890', 'K35.891']", "['K81.2', 'K81.0', 'K81.1', 'K81.9', 'K82.A1', 'K82.A2', 'K80.20']", "['K94.02', 'K94.12', 'K94.22', 'K94.32', 'N99.511', 'A02.9', 'A31.0']", "['K57.00', 'K57.01', 'K57.12', 'K57.13', 'K57.20', 'K57.21', 'K57.32']", "['A18.31', 'A54.85', 'A74.81', 'K65.8', 'K65.9', 'K65.0', 'K65.2']"] | ['tigecycline', 'ceftriaxone sodium + metronidazole'] | ['[H][C@@]12CC3=C(C=C(NC(=O)CNC(C)(C)C)C(O)=C3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2)N(C)C', '[H][C@]12SCC(CSC3=NC(=O)C(=O)NN3C)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\\C1=CSC(N)=N1)C(O)=O'] | Inclusion Criteria: - Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours. - Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain. Exclusion Criteria: - Cancer - Medicines that suppress the immune system - Dialysis | |
| 76 | NCT00195494 | completed | 1 | phase 4 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['etanercept', 'methotrexate', 'placebo'] | ['[O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O'] | Inclusion Criteria: - Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis - Has RA greater than or equal to 3 months and less than or equal to 2 years Exclusion Criteria: - Received any previous treatment with MTX - Received any previous treatment with ETN or other tumour necrosis factor antagonist | |
| 77 | NCT00195507 | completed | 1 | phase 4 | ['psoriasis'] | ["['L40.0', 'L40.4', 'L40.8', 'L40.9', 'L40.1', 'L40.50']"] | ['etanercept'] | ['[O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O'] | Inclusion Criteria: - Stable, active plaque psoriasis - Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate Exclusion Criteria: - Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study - Systemic psoriasis therapy within 28 days prior | |
| 78 | NCT00201643 | completed | 1 | phase 4 | ['preterm delivery'] | ["['O60.10X1', 'O60.10X2', 'O60.10X3', 'O60.10X4', 'O60.10X5', 'O60.10X9', 'O60.00']"] | ['betamethasone or dexamethasone (2nd course of acs)', 'placebo'] | ['[H][C@]12CC3=C(C=C(OC)C=C3)[C@@]3(CCCC[C@]13[H])CCN2C'] | Inclusion Criteria: - 25 to 32 6/7 weeks gestation - Singleton or twin gestation - Received 1st course of betamethasone prior to 30 weeks' gestation - Began 1st course of betamethasone at least 14 days prior to randomization - Risk of delivery in next 7 days due to either maternal or fetal complication (e.g. preterm labor, severe preeclampsia, IUGR, etc.) - Intact membranes Exclusion Criteria: - Known major fetal anomalies (eg: anencephaly, renal agenesis etc…) - High order multiple gestation (triplets or higher) - Cervical dilation > 5 cm - Clinical chorioamnionitis prior to initiation of second course (two or more of the following; antepartum temperature > 38ºC (100.4ºF), uterine tenderness, foul smelling vaginal discharge or amniotic fluid, maternal tachycardia (>100beats/min), fetal tachycardia (>160 beats/min), or white blood cell count >20x109/L.define) - Ruptured membranes prior to initiation of second course of betamethasone - Already receiving corticosteroids for other conditions (e.g. Lupus, asthma) - Maternal condition contraindicating the use of steroids (e.g. HIV, active Tuberculosis) - Participation in conflicting study | |
| 79 | NCT00205699 | completed | 1 | phase 4 | ['aggression', 'attention deficit-hyperactivity', 'oppositional defiant disorder', 'pervasive development disorders', 'bipolar disorder'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']", "['F91.3']", "['F84.8', 'F84.9']", "['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['risperidone', 'olanzapine', 'aripiprazole'] | ['CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1', '[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C', 'ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl'] | Inclusion Criteria: - Aged 6-18 years - Generally healthy and a score of ≥ 18 on the Aberrant Behavior Checklist in the context of one or more Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) childhood psychiatric disorders, including conduct disorder, oppositional defiant disorder, disruptive behavior disorder, autism, pervasive developmental disorder, attention deficit disorder, schizophrenia and bipolar affective disorders - Children's Global Assessment Scale (CGAS) score ≤ 60 - Not previously treated with an antipsychotic; individual subjects with remote, brief prior antipsychotic exposure may be considered for enrollment by the PI on a case by case basis - Patient assent and informed consent obtained from the parent or guardian - No clinically significant (based on PI determination) changes in permitted medications (e.g., stimulants and selective serotonin reuptake inhibitors [SSRIs]) for approximately 1 month prior to Baseline evaluations Exclusion Criteria: - Active suicidality or primary dx of major depressive disorder - Any lifetime use of antipsychotics or non-serotonin selective reuptake inhibitor (non-SSRI) anti-depressants - The presence of any serious medical disorder, based on PI determination, that may confound the assessment of relevant biologic measures or diagnoses, including: - significant organ system dysfunction; - endocrine disease, including type 1 or type 2 diabetes mellitus; - coagulopathy; - anemia; - or acute infection. - Subjects regularly taking any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism, oral glucocorticoids (glucocorticoid inhalants and nasal sprays are permitted), antihistamines, sedating antihistamines (non-sedating antihistamines such as but not limited to Claritin (loratadine) and Zyrtec (cetirizine) are permitted), and certain mood stabilizing agents, as some medications may themselves worsen or otherwise alter weight gain, glucose and lipid regulation or otherwise make it difficult to assess the effects of the antipsychotic alone; (note that exposure to many psychotropic agents including stimulants and SSRI's is permitted in order to maintain the generalizability of the sample); - Intelligence quotient (IQ) < 70 (based on school records and/or evaluation by clinician) - current substance abuse - Past history or currently has dyskinesia - Stimulant dosage significantly higher (per PI judgment)than the equivalent of approximately 2mg/kg/day methylphenidate equivalent dose. | |
| 80 | NCT00210340 | withdrawn | lack of accrual | 0 | phase 1 | ['lymphoma, b cell'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['intrathecal rituximab'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | Inclusion Criteria: 1. Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL 2. Pathologically diagnosed CD20-positive NHL 3. Age ≥ 18 years 4. ECOG Performance Status 0 - 2 (See Appendix A) 5. Life expectancy of at least 1 month 6. Informed consent must be given according to national/local regulations before enrollment (See Appendix B) 7. Patients may have had prior CNS irradiation, intrathecal methotrexate, cytarabine or thiotepa for treatment of lymphomatous meningitis but these treatments must have completed at least two weeks before the study enrollment and the patients must have recovered from any reversible toxicity caused by prior treatments 8. Concurrent systemic chemotherapy is allowed with the exception of high-dose methotrexate (>500 mg/m2/day), high-dose cytarabine (>2 g/m2/day), high-dose thiotepa (>300 mg/m2/day) or investigational agents 9. No concurrent intrathecal chemotherapy other than rituximab 10. No severe impairment of bone marrow function (ANC >1.5x109/L, PLT >50x109/L), unless due to proven lymphoma involvement 11. No major impairment of renal function (serum creatinine < 1,5 x upper normal) or liver function (ASAT/ALAT < 2,5 upper normal, total bilirubin <2,5x upper normal), unless due to proven lymphoma involvement 12. No evidence of active opportunistic infections 13. No HIV infection 14. No pregnant or lactating status 15. Appropriate contraceptive method in women of childbearing potential or men 16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 17. Absence of a obstructive hydrocephalus or compartimentalization of CSF flow. |
| 81 | NCT00216437 | terminated | lack of accrual | 0 | phase 1 | ['cancer of liver'] | ["['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'D37.6', 'C22.9']"] | ['capecitabine (xeloda)'] | ['CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. - Age >18 years - Ambulatory outpatients (if applicable), with Karnofsky performance status of >60 - Histologically or cytologically confirmed unresectable hepatocellular carcinoma, liver mets with no evidence of extrahepatic disease, or cholangiocarcinoma. (see exclusion criteria 10) - At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques. - Protocol Specific Laboratory Values as described below in section 6.9 number15. - Has a negative serum pregnancy test within 7 days prior to start of therapy (female patients of childbearing potential). - Have concomitant medications been reviewed with patient to address contraindicated medications described in protocol section 6.2.8 and have precautions been taken as recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine, Anticoagulants, Phenytoin, and Laxatives. Exclusion Criteria: - Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration - Life expectancy < 3 months. - Serious, uncontrolled, concurrent infection(s). - Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 12 months earlier). - Prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil or known DPD deficiency. - Completion of previous chemotherapy regimen < four weeks prior to the start of study treatment, or with related toxicities unresolved prior to the start of study treatment. - Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer. - Participation in any investigational drug study within 4 weeks preceding the start of study treatment. - Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. - Evidence of extrahepatic disease or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake - Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. - Major surgery within 4 weeks of the start of study treatment, without complete recovery. - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. - Known, existing uncontrolled coagulopathy - Any of the following laboratory values: - Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L) - Impaired renal function (estimated creatinine clearance <50ml/min as calculated with Cockroft-Gault equation. - Serum bilirubin > 2.0 x upper normal limit. - AST, ALT (SGOT/SGPT) > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases). - Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases). - Unwillingness to give written informed consent or provide HIPAA privacy authorization. - Unwillingness to participate or inability to comply with the protocol for the duration of the study. - Patient taking a contraindicated medication(s) described in section 6.2.8 (see inclusion criteria #8 for list of agents) and no appropriate substitute agent is available, or patient unable or refuses to take substitute agent. |
| 82 | NCT00220636 | completed | 1 | phase 4 | ['depressive disorder, major'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['aripiprazole'] | ['ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl'] | Inclusion Criteria: - Male and female outpatients between the ages of 18 and 70. - Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type - Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline - Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2) - Patients who agree to use acceptable method of birth control throughout the study Exclusion Criteria: - Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia. - Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol. - Patients who are pregnant or nursing women. - Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening - Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, HIV (by report of patient). - Patients with a history of seizures. | |
| 83 | NCT00225251 | completed | 1 | phase 4 | ['dysthymic disorder'] | ["['F34.1']"] | ['bupropion xl'] | ['CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1'] | Inclusion Criteria: - Male and female outpatients 18-65 years of age. - Patients with a Diagnostic and Statistical Manual Fourth Edition (DSM-IV) diagnosis of dysthymic disorder, early onset. - Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline. Exclusion Criteria: - Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders. - Patients who are pregnant or nursing women. - Patients with a principal diagnosis meeting DSM-IV criteria for: Major Depressive disorder, Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder - Patients who have a current or prior diagnosis of Anorexia Nervosa or Bulimia - Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol. - Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: - Report of having a specific plan for killing themselves, - A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors), or - A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week's dose of medication). - Patients with a history of recurrent Grand Mal seizures or at risk of Grand Mal seizures, and those with other medical conditions in which Wellbutrin XL would be contraindicated, including a history of head trauma. - Use of any psychotropic medication within 1 week of starting study medication - Use of a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) within the 14 days prior to the initial dose of study medication. - Use of fluoxetine within 28 days of the initial dose of study medication. - Use of Zyban® or other forms of bupropion hydrochloride (i.e. Wellbutrin immediate release or Wellbutrin Sustained Release (SR)) within 2 weeks of the initial dose of medication. - Patients who have failed to respond to adequate trials (minimum of six consecutive weeks) of two different classes of antidepressant medication (see Table 1 for definitions of an adequate trial.) - Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic or neurologic disease, or any clinically significant laboratory abnormality. - Patients who have begun a course of psychotherapy within 3 months of starting the study, or who plan to terminate an ongoing psychotherapy prior to the end of the study. | |
| 84 | NCT00230971 | completed | 1 | phase 4 | ['appendicitis', 'cholecystitis', 'diverticulitis', 'intra-abdominal abscess', 'intra-abdominal infection', 'peritonitis'] | ["['K36', 'K37', 'K35.80', 'K35.20', 'K35.21', 'K35.890', 'K35.891']", "['K81.2', 'K81.0', 'K81.1', 'K81.9', 'K82.A1', 'K82.A2', 'K80.20']", "['K57.00', 'K57.01', 'K57.12', 'K57.13', 'K57.20', 'K57.21', 'K57.32']", "['D18.03', 'C83.73', 'C84.03', 'C84.13', 'C81.73', 'C81.93', 'C82.93']", "['D18.03', 'C83.73', 'C84.03', 'C84.13', 'C81.73', 'C81.93', 'C82.93']", "['A18.31', 'A54.85', 'A74.81', 'K65.8', 'K65.9', 'K65.0', 'K65.2']"] | ['tigecycline', 'ceftriaxone plus metronidazole'] | ['[H][C@@]12CC3=C(C=C(NC(=O)CNC(C)(C)C)C(O)=C3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2)N(C)C', '[H][C@]12SCC(CSC3=NC(=O)C(=O)NN3C)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\\C1=CSC(N)=N1)C(O)=O'] | Inclusion Criteria: - Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours. - Fever plus other symptoms such as nausea, vomiting, abdominal pain. Exclusion Criteria: - Cancer - Medicines that suppress the immune system - Dialysis | |
| 85 | NCT00233480 | completed | 1 | phase 4 | ['heart failure, congestive'] | ["['I50.20', 'I50.21', 'I50.22', 'I50.30', 'I50.31', 'I50.32', 'I50.40']"] | ['atorvastatin', 'placebo'] | ['CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1'] | Inclusion Criteria: - Age≥18 years old - LVEF ≤ 35%, as documented by echocardiography, radionuclide ventriculography, gated SPECT, or contrast ventriculography within past 6 months - Symptomatic HF (NYHA II-IV) or current NYHA I with history of symptomatic HF within the last year - Stable doses of optimal HF medical therapy, unless documented contraindication. Exclusion Criteria: - Ischemic etiology of HF, defined as the presence of at least one of the following four criteria; angiographic evidence of > 50% lesion in 1 or more of the 3 major epicardial vessels; history of myocardial infarction; history of revascularization procedure; evidence of significant perfusion defect in the setting of ischemic symptoms. - Clinical indication for statin treatment - coronary artery, cerebrovascular, or peripheral vascular disease - Major cardiovascular event or surgical procedure within past 8 weeks - LDL<70 mg/dL - HF secondary to congenital heart disease or uncorrected valvular disease - Treatment with statin within past 2 months - Pregnancy - Contraindication to statin: moderate liver disease, AST/ALT > 150 U/ L, known hypersensitivity - Likely to receive heart transplant within 3 months - Known peripheral or autonomic neuropathy | |
| 86 | NCT00234065 | completed | 1 | phase 4 | ['cerebral infarction'] | ["['I63.89', 'I63.9', 'I69.320', 'I69.321', 'I69.322', 'I69.390', 'I69.391']"] | ['cilostazol', 'aspirin'] | ['O=C1CCC2=C(N1)C=CC(OCCCCC1=NN=NN1C1CCCCC1)=C2', '[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl'] | Inclusion Criteria: 1. Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction 2. Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI 3. Patients aged 20 to 80 years (inclusive) at time of consent 4. Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale 5. Patients without asymptomatic cerebral infarction 6. Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction 7. Patients without severe disturbances/impairments following occurrence of cerebral Exclusion Criteria: 1. Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body) 2. Pregnant, possibly pregnant, or nursing women 3. Patients with ischemic heart failure 4. Patients with peptic ulcer 5. Patients with severer blood disorders 6. Patients with severe hepatic or renal 7. Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study 8. Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets 9. Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma 10. Patients who are being treated with ticlopidine hydrochloride 11. Patients who are participating in another study for an investigational drug 12. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators | |
| 87 | NCT00237666 | completed | 1 | phase 4 | ['bipolar ii disorder', 'major depressive episode'] | ["['F31.81']", "['F32.0', 'F32.1', 'F32.9', 'F32.4', 'F32.5', 'F32.2', 'F32.3']"] | ['ziprasidone'] | ['ClC1=C(CCN2CCN(CC2)C2=NSC3=CC=CC=C23)C=C2CC(=O)NC2=C1'] | Inclusion Criteria: - patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania - patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration - minimum score of 18 on the 17-item HAM-D at screen and baseline Exclusion Criteria: - patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia - patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture - Suicidal ideation or history that makes participation in a clinical trial unduly risky - unstable medical conditions or any abnormality in thyroid function - patients with a QTc of 450msec or greater on the initial ECG - patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics - the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment - patients with dementia or substance abuse in the last 6 months - pregnant or lactating women will be excluded, as will those not using adequate forms of contraception | |
| 88 | NCT00240981 | terminated | higher incidence of cardiovascular events in the testosterone arm of the trial. decision taken by the dsmb on december 31st, 2009. | 1 | phase 4 | ['sarcopenia', 'hypogonadism', 'muscular diseases'] | ["['M62.84']", "['G71.00', 'G71.02', 'G71.11', 'G12.9', 'G71.09', 'N36.44', 'G12.1']"] | ['topical testosterone gel 1% (active formulation)', 'topical gel (placebo formulation)'] | ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C'] | Inclusion Criteria: - Community dwelling, ages 65 and older - Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground - A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment) - Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL - Without dementia (Mini-Mental State Examination [MMSE] score > 24) Exclusion Criteria: - Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year - Alcohol or drug abuse - Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day) - Prostate cancer, breast cancer or other cancers with life expectancy < 5 years - Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems - Any neurological condition that would impact cognitive functioning including: - epilepsy - multiple sclerosis - HIV - Parkinson's disease - stroke - other focal lesion - Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months - Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21 - Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry - Abnormal laboratory values (at discretion of principal investigator) - Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg - Body mass index > 40 kg/m2 - Untreated severe obstructive sleep apnea |
| 89 | NCT00241176 | completed | 1 | phase 4 | ["tourette's syndrome", 'tic disorders'] | ["['F95.2']", "['F95.0', 'F95.9', 'F95.1', 'F95.8']"] | ['aripiprazole'] | ['ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl'] | Inclusion Criteria: - Child or adolescent must be 7 to 18 years of age (inclusive) when informed consent is obtained. - Must meet full criteria for Tourette's Disorder or chronic motor tic disorder. - Must have failed to respond to an adequate trial, as determined by the investigator, of clonidine, guanfacine, or neuroleptic medication in the past. - Tics are causing significant distress or impairment, as determined by parent/subject and principal investigator, on current treatment regimen. - Laboratory results, including serum chemistries, hematology, and urinalysis, must show no significant abnormalities (significant is defined as laboratory values requiring acute medical intervention). - Must be able to swallow pills. - Must be of normal intelligence in the judgment of the investigator. - Must possess an educational level, degree of understanding and command of the English language to enable them to communicate suitably with the investigator and study coordinator, and to understand the nature of the study. - Subjects and their legal representatives must be considered reliable. - Written informed consent of parents and subjects (ages 18 and above) and assent of subjects ages 7-17 will be obtained. Exclusion Criteria: - Organic brain disease, for example, traumatic brain injury residua. - Mental retardation as defined by the DSM-IV-TR. - A history of seizure disorder (other than febrile seizure). - A history of Sydenham's Chorea. - Autism, schizophrenia, other psychotic disorder, or bipolar disorder. - A primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment. - A neurological disorder other than a tic disorder. - A major medical illness. - Females who are of child bearing age who are unwilling to use birth control or who are pregnant, as determined by serum pregnancy test at baseline assessment, or lactating. - Have a past or current history of substance dependence and/or a current history of substance abuse or who fail baseline toxic screen. - Have any clinically significant abnormal laboratory result at baseline screening including EKG, or blood tests. - Have a history of ongoing or previously undisclosed child abuse (risk of removal from home would not allow for consistent caretaker ratings). | |
| 90 | NCT00241904 | completed | 1 | phase 4 | ['cardiovascular diseases', 'heart diseases', 'coronary disease', 'diabetes mellitus', 'atherosclerosis', 'cerebral arteriosclerosis', 'hypertension'] | ["['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']", "['I11.0', 'I11.9', 'I27.1', 'I51.9', 'I09.9', 'I27.9', 'I01.8']", "['I25.10', 'I25.110', 'I25.119', 'I25.111', 'I25.118']", "['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']", "['I67.2', 'I70.90', 'I70.91', 'I70.0', 'I70.1', 'I70.8', 'I25.83']", "['B42.81', 'B45.1', 'G93.0', 'G93.6', 'I67.2', 'I67.82', 'I63.6']", "['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['antiplatelet agents', 'beta blocker', 'ace inhibitors'] | ['CC(=O)OC1=CC=CC=C1C(O)=O', 'CC(C)NCC(O)COC1=CC=C(COCCOC(C)C)C=C1', 'NCCCC[C@H](N[C@@H](CCC1=CC=CC=C1)C(O)=O)C(=O)N1CCC[C@H]1C(O)=O'] | Inclusion Criteria: - Currently receiving medical care at Johns Hopkins University - African American or Caucasian and have diagnosed CVD, defined as a prior myocardial infarction, revascularization procedure for coronary disease, ischemic heart disease, stroke, or have diagnosed type 2 diabetes and not receiving any therapy - Have either no LDL-C in their medical record during the 12 months prior to study entry or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering pharmacotherapy - Have either no blood pressure recorded in their medical record during the 12 months prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if the participant is diabetic or has renal insufficiency - If the participant is diabetic he or she has to either have no HbA1c recorded during the 12 months prior to study entry or HbA1c of 7 percent or greater Exclusion criteria: - A serious life-threatening noncardiac comorbidity with a life expectancy of less than 5 years - A serious physician-recorded psychiatric morbidity that would interfere with the study - Sufficient neurological impairment that would interfere with the study | |
| 91 | NCT00245960 | completed | 1 | phase 4 | ['psoriatic arthritis'] | ["['L40.52']"] | ['etanercept'] | ['[O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O'] | Inclusion Criteria: - 18 years of age or older at time of consent - Active Psoriatic Arthritis - Clinically stable, plaque psoriasis involving more than 10% of the body surface area Exclusion Criteria: - Evidence of skin conditions other than psoriasis that would interfere with skin examinations. - Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation - Prior exposure to any TNF-inhibitor, including etanercept | |
| 92 | NCT00247962 | completed | 1 | phase 4 | ['ankylosing spondylitis'] | ["['M08.1', 'M45.6', 'M45.2', 'M45.3', 'M45.4', 'M45.5', 'M45.7']"] | ['etanercept', 'sulphasalazine (ssz)'] | ['[O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O', 'OC(=O)C1=CC(=CC=C1O)\\N=N\\C1=CC=C(C=C1)S(=O)(=O)NC1=NC=CC=C1'] | Inclusion Criteria: - Clinical diagnosis of ankylosing spondylitis - Active ankylosing spondylitis Exclusion Criteria: - Complete ankylosis of spine - Previous treatment with etanercept | |
| 93 | NCT00251589 | terminated | this trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date. | 0 | phase 1/phase 2 | ['carcinoma, non-small-cell lung'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['vorinostat', 'vorinostat', 'vorinostat', 'vorinostat', 'erlotinib'] | ['ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1', 'ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1', 'ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1', 'ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1', 'COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2'] | Inclusion Criteria: - Males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for NSCLC. - Patients must have proven disease by CT scan or MRI. - Patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug. - Patients must be 2 weeks out from radiation therapy. - At screening the patient must have normal lab results and can not be pregnant. - Women and men must agree to practice adequate birth control during the study. - Patient has the ability to understand and sign the consent form. Exclusion Criteria: - Patient had prior treatment with vorinostat or erlotinib. - Patient has any of the following conditions: active infections including hepatitis B or C, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy. |
| 94 | NCT00253318 | terminated | toxicity and lack of efficacy | 0 | phase 1 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['docetaxel', 'rad001', 'dexamethasone'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', '[H][C@]12CC3=C(C=C(OC)C=C3)[C@@]3(CCCC[C@]13[H])CCN2C'] | Inclusion Criteria: 1. 18 years of age or older. 2. Diagnosis of metastatic breast cancer with at least one measurable or evaluable lesion. For the phase II portion of the study patients will be required to have measurable disease. Response will be determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 3. No limit on the prior number of chemotherapies for the phase I portion of the study. No more than one prior chemotherapy regimen for the phase II portion of the study. 4. Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and potential risks by the investigator with the aid of written information. 5. Adequate bone marrow function as shown by: Absolute neutrophil count (ANC) > or = 1.5 times 10(9)/L, Platelets > or = 100 times 10(9)/L, Hgb > or = 10g/dL. 6. Normal renal function as shown by serum creatinine < or = 1.5 times Upper Limit of Normal (ULN). 7. Hepatic Function Variables: - Bilirubin < or = ULN - Alkaline phosphatase < or = 5 times ULN. If alkaline phosphatase is < or = 2.5 times ULN, ALT/AST must be < or = 2.0 times ULN. If alkaline phosphatase is > 2.5 but < or = 5 times ULN, ALT/AST must be < or = 1.5 times ULN 8. Performance Status 0-2 on the World Health Organization (WHO) scale. Exclusion Criteria: 1. Patients enrolled in the Phase I portion of the trial may have received prior docetaxel in the adjuvant or metastatic setting. Patients enrolled in the Phase II portion of the trial will not be considered eligible if they have received prior docetaxel as treatment for metastatic breast cancer. For the purposes of this protocol, patients who develop systemic metastasis < 6 months from adjuvant docetaxel will be considered to have had treatment with docetaxel for metastatic breast cancer and will be ineligible for protocol participation. 2. Patients with a history of thromboembolism within the prior 6 months or active thrombophlebitis. 3. For the phase I portion of the study, patients with grade > 2 neuropathy, for the phase II portion of the trial, patients with > or = grade 2 neuropathy. 4. For the phase I portion of the trial, patients with treated brain metastasis that are stable for 3 months will be eligible for protocol participation. However, patients with brain metastasis will be excluded from the phase II portion of the trial. 5. Patients with an uncontrolled infection. 6. Patients with a known history of HIV seropositivity. 7. Patients with an active, bleeding diathesis, or on oral anti-vitamin K medication (except patients receiving 1 mg of warfarin to prevent central venous catheter thrombosis). 8. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration). 9. Patients with impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). 10. Patients who received any other investigational drugs within the preceding 30 days. 11. Patients who have received mitomycin C or nitrosourea. 12. Patients receiving anti-neoplastic therapy less than 14 days prior to entry onto this study or who have not recovered from the toxic effects of such therapy. 13. Patients who received radiation therapy within 3 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy. 14. Patients who had surgery within 2 weeks prior to entry on this study or who have not recovered from the side effects of such therapy. 15. Patients with a history of noncompliance to medical regimens. 16. Patients unwilling to or unable to comply with the protocol. 17. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 or patients taking lithium chloride. |
| 95 | NCT00258258 | terminated | withdrawn due to low accrual | 0 | phase 1 | ['multiple myeloma and plasma cell neoplasm'] | ["['C96.20', 'C96.29', 'D47.09']"] | ['paricalcitol', 'zoledronic acid'] | ['CC(C)[C@@H](C)\\C=C\\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)CCC1=C', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Diagnosis of relapsed or refractory multiple myeloma (MM) or other plasma cell disorder (PCD) - At least one previous treatment for MM or PCD required PATIENT CHARACTERISTICS: Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Not specified Renal - Calcium ≤ 10.5 mg/dL - No renal stone formation within the past 5 years for patients who have had curative therapy for a condition associated with the risk of stones (e.g., hyperparathyroidism, bladder dysfunction, obstructive uropathy) OR had a single episode of confirmed urolithiasis - No calculi in urinary tract confirmed by renal ultrasonography, kidney, ureter, and bladder (KUB) x-ray, or other imaging modality Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No uncontrolled cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during study and for 3 months after study completion - No osteonecrosis of the jaw - No history of allergic reaction attributed to compounds of similar chemical or biological composition of calcitriol, paricalcitol, or zoledronate - No uncontrolled intercurrent illness that would preclude study compliance - No ongoing or active infection - No psychiatric illness or social situation that may preclude study compliance PRIOR CONCURRENT THERAPY: Chemotherapy - More than 4 weeks since prior chemotherapy Endocrine - More than 4 weeks since prior high-dose steroids Other - No other concurrent investigational agents or therapies for multiple myeloma or plasma cell disorders - No concurrent digoxin |
| 96 | NCT00261443 | completed | 1 | phase 4 | ['bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['lithium or valproate with placebo (pbo)', 'lithium or valproate with aripiprazole'] | ['[Li+].[Li+].[Li+].OC(CC([O-])=O)(CC([O-])=O)C([O-])=O', 'ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl'] | Inclusion Criteria: - Men and women > or = to 18 years of age meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic. | |
| 97 | NCT00264290 | completed | 1 | phase 4 | ['hiv infections', 'cytomegalovirus infections'] | ["['Z21']", "['P35.1']"] | ['valganciclovir', 'placebo'] | ['CC(C)[C@H](N)C(=O)OCC(CO)OCN1C=NC2=C1NC(N)=NC2=O'] | Inclusion Criteria: - Infection with HIV >1 year in duration. - Age >18 - Cytomegalovirus (CMV) antibody positive. - All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at screening <350 cells/mm3 - On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition) for the preceding 6 months. - 90% adherence to antiretroviral therapy within the preceding 30 days. - Females of childbearing potential must have a negative serum pregnancy test at screening and all subjects must agree to use a double-barrier method of contraception throughout the study period. - Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10% Exclusion Criteria: - Patients intending to modify antiretroviral therapy in the next 16 weeks. - Serious illness requiring hospitalization or parental antibiotics within preceding 3 months. - Evidence of active symptomatic CMV end-organ disease. - Treatment with valganciclovir or ganciclovir in the past 30 days. - Concurrent treatment with immunomodulatory drugs. - Concurrent treatment with nephrotoxic drugs - Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute. - Men who are considering having children will also be excluded given potential effects of valganciclovir on spermatogenesis. - Pregnant or breastfeeding women | |
| 98 | NCT00264303 | completed | 1 | phase 4 | ['chronic idiopathic urticaria'] | ["['E20.0', 'I95.0', 'L50.1', 'D61.3', 'G24.2', 'G24.4', 'G60.3']"] | ['levocetirizine', 'desloratadine'] | ['OC(=O)COCCN1CCN(CC1)[C@H](C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'ClC1=CC2=C(C=C1)C(=C1CCNCC1)C1=C(CC2)C=CC=N1'] | Inclusion Criteria: - At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause - At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity. Exclusion Criteria: - Any condition that would interfere with the evaluation of the therapeutic response. | |
| 99 | NCT00267293 | completed | 1 | phase 4 | ['fever'] | ["['A78', 'A79.0', 'A93.1', 'A96.2', 'R50.82', 'R50.83', 'R50.9']"] | ['acetaminophen', 'ibuprofen'] | ['NCC(CC(O)=O)C1=CC=C(Cl)C=C1', '[H][C@@]12OC3=C(OC)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O'] | Inclusion Criteria: - Age 6 months - 7 years of age at time of the fever. - Initial temperature of 38.0C (100.4F) or more. - Ability to cooperate with serial temporal artery temperature measurements. - Ability to take medications by mouth. - Willingness of the child's guardian/sponsor to give informed consent Exclusion Criteria: - Patients who have received acetaminophen within 6 hours of presentation, or ibuprofen, aspirin, or other non-steroidal anti-inflammatory medications within 8 hours of presentation. - Patients >=3 years of age that have received narcotics in the previous 24 hours. - Children with weight >60 kg. Treatment of children with weights >60 kg will result in greater than recommended adult doses of the medications. - History of adverse reaction to any study medication ingredient. - History of diabetes mellitis, renal dysfunction, hepatic dysfunction, or thrombocytopenia. - Presence of moderate or severe dehydration. - Inclusion in the trial on 3 previous occasions - Medical judgment that the severity of the underlying illness prohibits inclusion. | |
| 100 | NCT00268255 | withdrawn | study never moved forward with accrual. | 0 | phase 1/phase 2 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['gefitinib'] | ['COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) - Any non-small cell histology allowed - T1-3, N0* disease - No metastatic disease - Refused or ineligible for surgery - Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: *No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance PATIENT CHARACTERISTICS: Performance status - Any performance status Life expectancy - At least 1 year Hematopoietic - No restrictions Hepatic - No restrictions Renal - Creatinine ≤ CTC grade 2 Pulmonary - No clinically active interstitial lung disease - Chronic, stable, asymptomatic radiographic changes allowed Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal contraception - No known severe hypersensitivity to gefitinib or any of the excipients of this product - No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix - No active or uncontrolled infection - No uncontrolled systemic disease - No psychiatric illness or other severe medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy - No prior chemotherapy Radiotherapy - No prior radiotherapy to the chest or mediastinum - No concurrent elective nodal irradiation Surgery - Recovered from prior surgery - No concurrent ophthalmic surgery Other - Recovered from all other prior anticancer therapy (alopecia allowed) - More than 30 days since prior nonapproved or investigational agents - No concurrent CYP3A4 inducers, including any of the following: - Phenytoin - Carbamazepine - Barbiturates - Rifampin - Phenobarbital - Hypericum perforatum (St. John's wort) - No concurrent systemic retinoids |