Aminopterin in Treating Patients With Refractory Leukemia
NCT ID: NCT00003305
Last Updated: 2014-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
1997-07-31
2007-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory leukemia.
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Detailed Description
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OUTLINE: This is an open label study. Patients are stratified according to age and type of leukemia: Stratum I: Under 20 years old with acute lymphoblastic leukemia (ALL) in second or greater relapse Stratum II: Greater than 20 years old with ALL in first or greater relapse Stratum III: Patients of any age with acute myelogenous leukemia (AML) in first or greater relapse Patients receive aminopterin every 12 hours for 2 doses weekly for 4 weeks. Aminopterin is administered intravenously over 20 minutes for the first, second, and fourth doses, and orally for the third dose. The fifth and all subsequent doses are administered orally if bioavailability is acceptable. Patients receive oral leucovorin calcium every 12 hours for 2 doses beginning 24 hours after the last dose of aminopterin each week. If toxicity is limited for 2 consecutive weeks, the dose of leucovorin calcium is decreased to 1 dose administered 24 hours after the last dose of aminopterin each week. If this schedule is tolerated for 2 consecutive weeks, then leucovorin calcium is discontinued. Patients continue therapy for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months.
PROJECTED ACCRUAL: This study will accrue a maximum of 25 patients per stratum, for a total of 75 patients, within 3 years.
Conditions
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Study Design
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TREATMENT
Interventions
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aminopterin
leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL ALT no greater than 5 times upper limit of normal Renal: Creatinine normal for age Cardiovascular: No unstable angina No uncontrolled arrhythmia Pulmonary: No third space effusion Other: No severe uncontrolled infection Adequate nutritional status At least third percentile for weight Normal total serum protein Normal albumin/globulin ratio No serious concurrent physical or mental illness Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior bone marrow transplantation Recovered from prior biologic therapy No concurrent anticancer biologic therapy Chemotherapy: Recovered from prior chemotherapy No concurrent anticancer chemotherapy Endocrine therapy: Recovered from prior endocrine therapy No concurrent anticancer endocrine therapy No concurrent dexamethasone or other steroids as antiemetic agents Radiotherapy: No concurrent anticancer radiotherapy Surgery: Not specified Other: No concurrent dairy products for 2-4 hours before, during, or 2-4 hours after study drug No concurrent trimethoprim-sulfamethoxazole or dapsone as prophylaxis for Pneumocystis infection No concurrent multivitamins containing folic acid
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Principal Investigators
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Barton A. Kamen, MD, PhD
Role: STUDY_CHAIR
Rutgers Cancer Institute of New Jersey
Locations
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Advanced Urology Medical Center
Anaheim, California, United States
South Coast Urological Medical Group
Laguana Hills, California, United States
Urology Specialists, P.C.
Waterbury, Connecticut, United States
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center
Sarasota, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
206 Research Associates
Greenbelt, Maryland, United States
Mid Atlantic Clinical Research
Rockville, Maryland, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Medical & Clinical Research Associates, LLC
Bay Shore, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Urology Centers of North Texas
Dallas, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Countries
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References
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Cole PD, Drachtman RA, Masterson M, Smith AK, Glod J, Zebala JA, Lisi S, Drapala DA, Kamen BA. Phase 2B trial of aminopterin in multiagent therapy for children with newly diagnosed acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2008 Jun;62(1):65-75. doi: 10.1007/s00280-007-0576-7. Epub 2007 Sep 2.
Other Identifiers
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ILEX-AMT-002/1997
Identifier Type: -
Identifier Source: secondary_id
UTSMC-AMT-002/1997
Identifier Type: -
Identifier Source: secondary_id
UTSMC-FDR001458
Identifier Type: -
Identifier Source: secondary_id
NCI-V99-1534
Identifier Type: -
Identifier Source: secondary_id
CDR0000066248
Identifier Type: -
Identifier Source: org_study_id
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