Status:
COMPLETED
Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias
Lead Sponsor:
Vion Pharmaceuticals
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Tem...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of temozolomide and VNP40101M in patients with relapsed or refractory leukemias. * Determine the toxic effects of this regimen in these patients. O...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Acute myeloid leukemia
- Acute lymphoblastic leukemia
- Chronic myelogenous leukemia in blast crisis
- Relapsed or refractory disease
- No known standard therapy that is anticipated to result in a durable remission exists
- CNS leukemia allowed
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT or AST ≤ 3 times ULN
- Chronic hepatitis allowed
- Renal
- Creatinine ≤ 2.0 mg/dL
- Cardiovascular
- No active heart disease, including any of the following:
- Myocardial infarction within the past 3 months
- Symptomatic coronary artery disease
- Arrhythmias not controlled by medication
- Uncontrolled congestive heart failure
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No uncontrolled active infection
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Concurrent hydroxyurea allowed within the first 10 days of study drug administration for control of elevated blast levels or platelet counts
- Maximum hydroxyurea dose 5 g daily
- No persistent chronic toxic effects from prior chemotherapy \> grade 1
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- Recovered from all prior therapy
- At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressive disease)
- No more than 2 leukapheresis procedures within the first 10 days of study drug administration for control of elevated blast levels or platelet counts
- No concurrent disulfiram
- No other concurrent anticancer drugs
- No other concurrent standard or investigational treatment for leukemia
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00098436
Start Date
September 1 2004
End Date
August 1 2008
Last Update
July 18 2013
Active Locations (4)
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1
American Health Network - North Illinois Street
Indianapolis, Indiana, United States, 46202
2
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
3
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
4
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195