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506U78 in Treating Patients With Refractory Hematologic Cancer
This study is no longer recruiting patients.
Sponsored by: | National Cancer Institute (NCI) Children's Cancer Group
Pediatric Oncology Group
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer.
Condition | Treatment or Intervention | Phase |
---|---|---|
recurrent childhood lymphoblastic lymphoma T-cell childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia |
Procedure: chemotherapy Drug: U78 Drug: cytarabine Drug: hydrocortisone Drug: methotrexate |
Phase II |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Compound 506U78 in Patients with Refractory T-Cell Malignancies
Study start: August 1998
OBJECTIVES: I. Determine the response rate to compound 506U78 (2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine) administered as a 1 hour infusion daily for 5 days in patients with recurrent T-cell malignancies. II. Determine the toxicities of compound 506U78 in this group of patients. III. Correlate the biochemical pharmacology of compound 506U78 (e.g., ara-G nucleotides in leukemic blasts and CSF concentrations) with clinical response. IV. Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies.
PROTOCOL OUTLINE: Patients are stratified according to disease characteristics: Group 1: T-cell ALL or NHL in first relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS) Group 2: T-cell ALL or NHL in second or later relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS) Group 3: T-cell ALL or NHL with positive bone marrow and CSF (greater than 5% bone marrow blasts and CNS 2 or 3 involvement) Group 4: Extramedullary relapse and less than 25% blasts in the bone marrow (excluding isolated CNS relapse) Group 1 receives a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity. The course repeats every 21 days. If a first relapse T-cell ALL study of higher priority is not open, then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response. Groups 2 and 4 receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy (TIT), consisting of methotrexate, cytarabine and hydrocortisone after consultation with study coordinator. TIT should be given every 12 weeks. Group 3 receives compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. TIT will be given on day 1 of weeks 1-4, 6, 9 and every 6 weeks for 12 weeks, and then every 9 weeks thereafter. This stratum is open.
PROJECTED ACCRUAL: A maximum of 148 patients (37 patients per stratum) will be accrued for this study.
Eligibility
Ages Eligible for Study: up to 21 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
Biologic therapy: No concurrent biologic therapy
Chemotherapy:
Endocrine therapy: No concurrent endocrine therapy
Radiotherapy: At least 6 weeks from administration of craniospinal or hemipelvic radiotherapy
Surgery: Not specified
--Patient Characteristics--
Age: 21 and under
Performance status: Karnofsky 50-100%
Life expectancy: At least 8 weeks
Hematopoietic: Not specified
Hepatic:
Renal:
Other: No severe uncontrolled infection
Location Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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