Overview

506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment

Status:
Terminated
Trial end date:
2002-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Criteria
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