Status:
COMPLETED
VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia
Lead Sponsor:
Vion Pharmaceuticals
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill mor...
Detailed Description
OBJECTIVES: * Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia . * Determine the toxic effects of this regimen in these patien...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Acute myelogenous leukemia (AML), meeting the following criteria:
- In first relapse after first treatment-induced complete remission (CR) (closed to accrual as of 06/09/05)
- Duration of first CR less than 12 months
- No prior treatment for first relapse except hydroxyurea
- FAB type M0, M1, M2, M4-7
- No acute promyelocytic leukemia
- No prior treatment with a standard induction regimen containing cytotoxic agents\* (for patients 60 years of age or older)
- High-risk myelodysplasia, meeting the following criteria:
- 60 years of age and over
- No prior cytotoxic chemotherapy\* except hydroxyurea
- Prior gemtuzumab ozogamicin allowed
- High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE: \*Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- ALT or AST ≤ 5 times upper limit of normal
- Chronic hepatitis allowed
- Renal
- Creatinine ≤ 2.0 mg/dL
- Cardiovascular
- No myocardial infarction within the past 3 months
- No symptomatic coronary artery disease
- No uncontrolled arrhythmias
- No uncontrolled congestive heart failure
- No other active heart disease
- Other
- No uncontrolled active infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment
- Chemotherapy
- See Disease Characteristics
- Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- Recovered from all prior therapy
- At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent
- No concurrent disulfiram (Antabuse)
- No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts
- No other concurrent treatment for leukemia, except hydroxyurea used during study treatment
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00083187
Start Date
November 1 2005
End Date
August 1 2008
Last Update
July 18 2013
Active Locations (5)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
2
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
3
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
4
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273