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

Vion Pharmaceuticals

Overview

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.

OBJECTIVES: * Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes. * Determine the maximum tolerated dose of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the antitumor effects of this drug in these patients. OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms

Interventions

laromustineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.