[c09aa8]: / clusters / clusters342final / clust_15.txt

Download this file

44 lines (43 with data), 6.3 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
Bilirubin =< 1.5 times normal 14 days prior to study entry
Off treatment > 14 years
Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of attention-deficit hyperactivity disorder (ADHD) does NOT exclude a child from participation
Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration
Use of finasteride within 30 days prior to registration
Laboratory values obtained =< 365* days prior to registration:* Note: Without medical situations that should change these parameters since they were done
Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =< grade 1
Uncontrolled diabetes: a glycated hemoglobin (Hg A1C) > 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
Child-Pugh score A within 14 days prior to study entry
Patients must start therapy within 7 calendar days of registration
Platelets >= 100,000/L (unsupported), within 14 days of registration and within 7 days of the start of treatment
Hemoglobin >= 8 g/dL (may be supported), within 14 days of registration and within 7 days of the start of treatment
Albumin >= 3 g/dL, within 14 days of registration and within 7 days of the start of treatment
Serum sodium and potassium within the institutional limits of normal, within 14 days of registration and within 7 days of the start of treatment
No other chemotherapy or radiation therapy within 14 days prior to registration
No investigational therapy within 14 days prior to registration
No G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteria
Unintentional weight loss > 10% within 30 days prior to registration
Evaluation by a radiation oncologist within 45 days prior to study registration
Evaluation by a medical oncologist within 45 days prior to study registration
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
Negative beta human chorionic gonadotropin (bHCG) within 14 days prior to study entry if patient is pre or perimenopausal
Patients must not have testicular involvement; if clinical or ultrasound findings are equivocal, biopsy must be performed; all tests for establishing testicular involvement must be completed within 14 days prior to registration
Radiographic confirmation of MBO is required prior to registration; scans may have been done before or after admission; scans done prior to admission must have been completed within 14 days prior to admission; computed tomography (CT) scans are preferred
No cardiac arrhythmias within 182 days of registration
Patient must not have received pegfilgrastim within 14 days of enrollment
CA19-9 must be performed within 14 days prior to registration
Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy, Note:* Post-chemotherapy restaging imaging must be completed no earlier than 56 days prior to Step 1 registration For patients with limited-stage small cell lung cancer who receive thoracic radiotherapy concomitant with chemotherapy, patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted; if consolidative thoracic radiotherapy is performed prior to study registration, then patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing thoracic radiotherapy
Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration
Patients must not have received any chemotherapy within 14 days prior to registration
Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration
Patients must have CA19-9 obtained within 14 days prior to registration; if CA19-9 is normal a carcinoembryonic antigen (CEA) must be tested within 14 days prior to registration
Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration
Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration
Patients must not have received enzymeinducing anticonvulsants within 14 days prior to enrollment
Whole blood transfusions in the last 120 days prior to entry to the study
Within less than or equal to 14 days prior to registration: Platelets >= 100 x 10^9/L
Within less than or equal to 14 days prior to registration: Glycosylated hemoglobin (HbA1c) < 7.0%
Patients who have had radiotherapy within 14 days prior to entering the study
Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine
Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib
CT or MRI within 14 days prior to start of study drug
Patients must not have had prior radiation therapy within 14 days prior to registration