VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia

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

Summary

RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: Hydroxyurea

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

• Acute myelogenous leukemia (AML), meeting the following criteria:

• In first relapse after first treatment-induced complete remission (CR) (closed to accrual as of 06/09/05)

• Duration of first CR less than 12 months

• No prior treatment for first relapse except hydroxyurea

• FAB type M0, M1, M2, M4-7

• No acute promyelocytic leukemia

• No prior treatment with a standard induction regimen containing cytotoxic agents* (for patients 60 years of age or older)

• High-risk myelodysplasia, meeting the following criteria:

• 60 years of age and over

• No prior cytotoxic chemotherapy* except hydroxyurea

• Prior gemtuzumab ozogamicin allowed

• High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE: *Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 2.0 mg/dL

• ALT or AST ≤ 5 times upper limit of normal

• Chronic hepatitis allowed

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months

• No symptomatic coronary artery disease

• No uncontrolled arrhythmias

• No uncontrolled congestive heart failure

• No other active heart disease

Other

• No uncontrolled active infection

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment

Chemotherapy

• See Disease Characteristics

• Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from all prior therapy

• At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent

• No concurrent disulfiram (Antabuse)

• No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts

• No other concurrent treatment for leukemia, except hydroxyurea used during study treatment

• No other concurrent investigational drugs