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506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
This study is no longer recruiting patients.
Sponsored by: | National Cancer Institute (NCI) Cancer and Leukemia Group B
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Information provided by: | National Cancer Institute (NCI) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Leukemia Lymphoma Multiple Myeloma |
Procedure: chemotherapy Drug: U78 |
Phase I |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma; Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 506U78 in Patients With Hematologic Malignancies and Renal or Hepatic Impairment
Study start: December 1999
OBJECTIVES: I. Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment. II. Establish dosing guidelines for this drug in this patient population. III. Determine the toxicities and pharmacokinetics of this drug in these patients.
PROTOCOL OUTLINE: Patients are stratified into 5 groups according to renal and hepatic function: Group 1: Normal renal function and normal hepatic function Group 2: Moderate renal impairment and normal hepatic function Group 3: Severe renal impairment and normal hepatic function Group 4: End stage renal impairment and normal hepatic function Group 5: Normal renal function and moderate hepatic impairment Group 1: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Groups 2-5: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Dose escalation occurs independently in each of the treatment groups. Cohorts of 3-6 patients receive escalating doses of 506U78 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Location Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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