Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00049686


Primary Contact:

Study Chair
Mario Sznol, MD
Vion Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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