Re-registration: ANC >= 1,500/mm^3
ANC ? 1500/mm3
Must have measurable MM
Prior treatment with MM-310
Granulocytes > 1500/mm^3
Measurable (>10mm x 10mm) contrast enhancing disease.
ANC must be ? 1500/mm3;
Patients with midline shift > 10mm
ANC >500/mm3.
Patients must have measurable disease, defined as lesions that can be accurately measure in in 2 perpendicular diameters with at least one diameter > 20mm and the other >10mm on conventional CT or MRI or 10mm x 10 mm by spiral CT.
PART II: ANC >= 1000 cells/mm^3
ANC >/= 800/mm3, Cohort 8 (PTCL): ANC >/= 1000/mm3
ANC* ? 1500/mm³ (? 1.5 x 10^9/L)
Lymphocytes* ? 500/mm³ (? 0.5 x 10^9/L)
Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ? 15 mm. The largest lesion should not exceed 15mm.
Subjects must not have an MRI defined target tumor that is within 10 mm of skin (defined as volume encompassing first 3 mm from skin surface)
Patients with lack of count recovery as defined by ANC > 500 cells/mm^3, non-transfused platelet count > 20,000 K/mm^3
Adequate bone marrow function: white blood cells (WBCs) ? 3,000/mm3, absolute neutrophil count (ANC) ? 1,500/mm3, hemoglobin ? 9 g/dL, and platelets ? 100,000/mm3
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
Absolute neutrophil count (ANC) >= 1500/mm^3; (ANC > 1000/mm^3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor)
Tumor size less than 5 mm
Absolute neutrophil count (ANC) >= 1.0 K/cu mm; for subjects with ANC < 1.0 K/cu mm due to significant marrow involvement by MCL, ANC must be > .5 K/cu mm
Adequate hematologic function (Platelets ? 60,000/mm3, lymphocytes ? 1,000/mm3, neutrophils ? 750/mm3, hemoglobin ? 10 g/dl).
Adequate hematological function, defined as ANC ? 1,500/mm3, Hb ? 9.0 g/dL, and platelet count ? 100,000/mm3.
ANC ?1,000/mm^3 (?1.0x10^9/L)
Evidence of MM disease progression any time prior to enrollment; progression from smoldering/asymptomatic MM to symptomatic MM is not exclusionary
Platelets >= 50,000/mm^3 or >= 30,000/mm^3 in the setting of marrow involvement by disease or splenomegaly due to disease
Patients with a ?20mm non-pedunculated colon polyp
Hematopoietic Function: WBC ? 2,500/mm3; ANC ? 1000/mm3; Hemoglobin ? 8 g/dL; Platelet count ? 50,000/mm3; Coagulation: INR ? 1.3.
Adequate hematologic function (Platelets ? 60,000/mm3, lymphocytes ? 1,000 mm3, neutrophils ? 750/mm3, hemoglobin ? 9.0 g/dl).
Adequate hematologic reserve obtained ? 2 weeks prior to entry: leukocytes ? 3,000 mm^3; absolute neutrophil count ? 1500 mm^3; platelets ? 100,000 mm^3
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
ANC > 1500/mm3, plt count > 100,000/mm3
ANC ?1500 cells/mm3
Has MM positive for t(11;14).
Adequate hematology without ongoing transfusional support (hemoglobin > 8 g/dL, ANC ? 1,500 per mm3, platelets > 100,000 per mm3)
Granulocytes >= 1,000/mm^3
A single measurable tumor that is at least 10.0 mm longest diameter (LDi) X 10.0 mm shortest diameter (SDi) and this tumor does not exceed 40.0 mm in LDi or SDi on Screening MRI
* one lesion must be ?10 mm and <100 mm in longest diameter, accessible for repeated intratumoral (IT) injection and accessible for baseline and on-treatment biopsies.
Patients must have adequate hematologic reserve as evidenced by absolute neutrophil count (ANC) >= 1500/mm^3 and platelets >= 100,000/mm^3
ANC ?1,000/mm^3 (?1.0 x 10^9/L)
Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
MM diagnostic criteria (all 3 required);
ABC count ? 40,000/mm
Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophils count ? 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL.
ANC: for patients with lymphoma ?750/mm3 (?0.75 × 10^9/L), for patients with advanced solid tumors ?1,000/mm3 (?1.0 × 10^9/L),
ANC ? 1,500 / mm3
ANC >= 1000 cells/mm^3 (1.0 x 10^9/L)
Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
Lymphocytes >= 700/mm^3
Patients must have measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment; lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis; the following measurement criteria are required (not counting tumor edema, as visualized by contrast enhanced magnetic resonance imaging [MRI] with slice thickness of 1.5 mm or smaller, unless prospective permission is obtained from the principal investigator [PI] allowing absence of contrast or thicker slices): \r\n* At least one CNS tumor measuring 10 mm or greater in longest diameter, OR  \r\n* At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring 3 mm or greater in longest diameter, for which the sum of the longest diameters is equal to or greater than 10 mm; patient may have additional tumors as well
PHASE II: Alternatively, with less BM involvement, an ANC >= 1000/mm^3, and platelet count >= 50,000 mm^3 is required
Granulocytes >= 1500/mm^3 within 4 weeks of enrollment
Less than 10 mm of cervical stromal invasion
Gastric or duodenal ulcer (at least 10 mm in size) within 10 mm of expected endoscopy puncture site(s) for photodynamic therapy (PDT)
Granulocytes >= 2,500/mm^3
Lymphocytes >= 1000/mm^3
Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L (75x103/mm3).
Unifocal malignant tumor that does not exceed 20mm in diameter and measures at least 5mm away from the skin and chest wall
Cluster of microcalcifications that do not exceed 10 mm in diameter and measures at least 5mm away from the skin and chest wall
Neutrophiles <1,500/mm3
ANC >= 1,500/mm^3
Recipients with agnogenic myeloid metaplasia must have at least 2 of the following features:\r\n* Hemoglobin < 10 g/dl, or > 10 g/dl with transfusion dependence\r\n* WBC < 4,000 or > 30,000/mm^3 or requires cytoreductive therapy to maintain\r\n* WBC < 30,000/mm\r\n* Abnormal cytogenetics including +8, 12p-
Granulocytes >= 1,000/mm^3
ANC ?1000/mm³
Adequate bone marrow reserve: ANC ?1500/mm3, platelets ?100,000/mm3
ANC >1500 cells/mm3
Patients should have adequate bone marrow function defined as a peripheral WBC >3,000/mm3 with an ANC >1500/mm3 and a platelet count >100,000/mm3.
Adequate hematologic function including ANC ? 1200/mm3, Hemoglobin ? 9 g/dL (transfusion is permitted), and platelets ? 100,000/mm3.
Patients with non-secretory or hyposecretory MM
Patients with nodal disease limited to micrometastases (pN1Mi, > 0.2 mm and =< 2 mm) or isolated tumor cells (pN0i+ < 0.2 mm)
ANC of >1000/mm3
ANC of >1000/mm3 independent of G-CSF
ANC of >1000/mm3 independent of G-CSF
MM diagnostic criteria (all 3 required):
Smoldering MM.
Smoldering MM.
Has a single lesion with a maximum size of ? 12 mm with ? 10 mm of capsular contact as confirmed by MR imaging,
Have had at least one prior episode of fever and neutropenia (ANC < 500/mm^3 or expected to fall below < 500/mm^3) during doxorubicin and cyclophosphamide (AC)
A single, biopsy-proven SISCCA as defined by the LAST criteria (=< 3 mm depth of invasion, horizontal spread of =< 7 mm, and completely excised with at least 1 mm margin clear of cancer irrespective of the amount of HSIL) documented per investigator assessment in combination with the pathology report within 16 weeks before Segment B enrollment
Be periodontally healthy; this is defined as all sites with attachment levels =< 2 mm and probing depths =< 3 mm) and caries-free, as evidenced by a DMF (decayed, missing, filled teeth) index of < 5
Lymphocytes > 500/ mm3
Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 – 1.00 mm in setting of ulceration, extensive regression
Mitotic rate >= 1/mm^2
Less than 5 mm distance of the tumor margin from a major vessel (> 7 mm in diameter)\r\n* This will not be considered exclusion when irreversible electroporation (IRE) is used
ANC ? 1000/mm3
At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm)
ANC ? 1500 mm3, platelets ? 100,000/mm3, hemoglobin ? 9 g/dL,