Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: Cytarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute myeloid leukemia (AML)

• Any WHO classification, excluding acute promyelocytic leukemia

• At least 10% blasts by bone marrow aspirate and/or biopsy

• In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen

• Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

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

• AST ≤ 3 times ULN

• Chronic hepatitis allowed

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months

• No uncontrolled arrhythmias

• No uncontrolled congestive heart failure

Pulmonary

• No severe chronic obstructive pulmonary disease

• No requirement for supplemental oxygen at rest

Immunologic

• No uncontrolled active infection

• Infections that are controlled and under active treatment with antibiotics allowed

• No evidence of invasive fungal infection by blood or tissue cultures

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies

• No other severe medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 12 hours since prior hydroxyurea

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior treatment while in first relapse except hydroxyurea

• No other concurrent standard or investigational treatment for AML

• No concurrent disulfiram (Antabuse®)