Status:
COMPLETED
Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia
Lead Sponsor:
Vion Pharmaceuticals
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * Compare the complete response (CR) and CR (with platelet count \< 100,000/mm\^3 but ≥ 20,000/mm\^3 \[transfusion independent for ≥ 7 consecutive days\]) (CRp) rates in patients...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML)
- Any WHO classification, excluding acute promyelocytic leukemia
- At least 10% blasts by bone marrow aspirate and/or biopsy
- In first relapse after achieving a first complete response (CR) OR CR (with platelet count \< 100,000/mm³ but ≥ 20,000/mm³ \[transfusion independent for ≥ 7 consecutive days\]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen
- Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Chronic hepatitis allowed
- Renal
- Creatinine ≤ 2.0 mg/dL
- Cardiovascular
- No myocardial infarction within the past 3 months
- No uncontrolled arrhythmias
- No uncontrolled congestive heart failure
- Pulmonary
- No severe chronic obstructive pulmonary disease
- No requirement for supplemental oxygen at rest
- Immunologic
- No uncontrolled active infection
- Infections that are controlled and under active treatment with antibiotics allowed
- No evidence of invasive fungal infection by blood or tissue cultures
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies
- No other severe medical condition that would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- At least 12 hours since prior hydroxyurea
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No prior treatment while in first relapse except hydroxyurea
- No other concurrent standard or investigational treatment for AML
- No concurrent disulfiram (Antabuse®)
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00112554
Start Date
March 1 2005
End Date
March 1 2008
Last Update
November 6 2013
Active Locations (62)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
3
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
4
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115