Aminopterin in Treating Patients With Refractory Leukemia
Sponsored by Genzyme, a Sanofi Company
About this trial
Last updated 11 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 18 years ago
What is this trial about?
What are the Participation Requirements?
DISEASE CHARACTERISTICS: Histologically proven acute leukemia of any histologic type that
is refractory to known effective therapy
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