VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

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

Summary

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 VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.

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

Details

• Lead Sponsor: Vion Pharmaceuticals

Criteria

DISEASE CHARACTERISTICS:

• Relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission OR

• Poor-risk myelodysplastic syndromes

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 3 times ULN

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months

• No symptomatic coronary artery disease

• No uncontrolled arrhythmia

• No uncontrolled congestive heart failure

Other

• No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy allowed

Chemotherapy

• At least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease

• At least 48 hours since prior hydroxyurea

Endocrine therapy

• Not specified

Radiotherapy

• Prior radiotherapy allowed

Surgery

• Not specified

Other

• No other concurrent standard or investigational treatment for leukemia

• No concurrent disulfiram