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



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

For Condition: Hairy Cell Leukemia,atypical chronic myeloid leukemia,myelodysplastic and myeloproliferative disease,Prolymphocytic Leukemia,chronic leukemia,acute leukemia
Status: No longer recruiting
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MarioSznol,  Study Chair,  Vion Pharmaceuticals

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4095
United States
 


Additional Information:
Study ID Numbers:  CDR0000258354;  VION-CLI-029,MDA-DM-02202
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049686

Other Myelodysplastic And Myeloproliferative Disease Studies:
1. A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia

2. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia

3. Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

4. Flavopiridol, Fludarabine, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma

5. UCN-01 and Fludarabine to Treat Lymphoma and Leukemia

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