Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temozolomide may also help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug. Giving temozolomide together with VNP40101M may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide and VNP40101M in treating patients with relapsed or refractory leukemias.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Acute myeloid leukemia

• Acute lymphoblastic leukemia

• Chronic myelogenous leukemia in blast crisis

• Relapsed or refractory disease

• No known standard therapy that is anticipated to result in a durable remission exists

• CNS leukemia allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT or AST ≤ 3 times ULN

• Chronic hepatitis allowed

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No active heart disease, including any of the following:

• Myocardial infarction within the past 3 months

• Symptomatic coronary artery disease

• Arrhythmias not controlled by medication

• Uncontrolled congestive heart failure

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Concurrent hydroxyurea allowed within the first 10 days of study drug administration for control of elevated blast levels or platelet counts

• Maximum hydroxyurea dose 5 g daily

• No persistent chronic toxic effects from prior chemotherapy > grade 1

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from all prior therapy

• At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressive disease)

• No more than 2 leukapheresis procedures within the first 10 days of study drug administration for control of elevated blast levels or platelet counts

• No concurrent disulfiram

• No other concurrent anticancer drugs

• No other concurrent standard or investigational treatment for leukemia