Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
NCT ID: NCT00003405
Last Updated: 2021-10-14
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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WITHDRAWN
PHASE2
INTERVENTIONAL
1998-04-30
1999-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, isotretinoin, and interferon alfa in treating patients who have acute myelogenous leukemia.
Detailed Description
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OUTLINE: Prior to treatment, patients undergo bone marrow aspirate and biopsy. On day -3, patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow aspirate and biopsy. Patients then receive amifostine IV over 5-7 minutes on the same day. Prior to chemotherapy on day 1, patient receive broxuridine IV over 60 minutes immediately followed by bone marrow aspirate and biopsy. Chemotherapy on day 1 consists of amifostine followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1 hour immediately after the second infusion of cytarabine. This course is repeated on day 5 after another bone marrow biopsy and aspirate. Starting on day 6, patients receive amifostine 3 times a week until day 28 or beyond. Patients who respond to treatment continue on to receive three courses of consolidation therapy. Consolidation courses 1 and 3 consist of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1, 2, and 3. Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours for 4 days. Twenty-four hours after each course of consolidation therapy, patients receive isotretinoin orally every day and interferon alfa subcutaneously every other day. Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next course of consolidation therapy. Following recovery from course 3 of consolidation therapy, patients continue to receive isotretinoin/interferon alfa until relapse. Patients in complete remission after the 3 courses of consolidation therapy receive isotretinoin/interferon alfa for 3 years. Patients are followed every 3 months for the first year, then every 6 months for the next 2 years.
PROJECTED ACCRUAL: There will be 40-45 patients accrued into this study.
Conditions
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Study Design
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TREATMENT
Interventions
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recombinant interferon alfa
amifostine trihydrate
bromodeoxyuridine
cytarabine
idarubicin
idoxuridine
isotretinoin
mitoxantrone hydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin greater than 2.0 mg/dL and no greater than 3.0 mg/dL allowed with 50% reduction in drug doses Renal: Creatinine less than 3.0 mg/dL Cardiovascular: No overt congestive heart failure No uncontrollable ventricular arrhythmias No uncontrollable hypertension If cardiac ejection fraction is less than 45% of predicted, an echocardiogram and a cardiac consult must be obtained to ascertain cardiac tolerance of anthracycline therapy Neurological: No cerebellar dysfunction Other: Fever, infection, or other complications of disease allowed Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon At least 2 weeks since prior hematopoietic growth factors (including erythropoietin) Chemotherapy: At least 2 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 2 weeks since prior retinoids
0 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rush University Medical Center
OTHER
Principal Investigators
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Philip D. Bonomi, MD
Role: STUDY_CHAIR
Rush University Medical Center
Locations
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Cook County Hospital
Chicago, Illinois, United States
Rush Cancer Institute
Chicago, Illinois, United States
Angelo P. Creticos, M.D. Cancer Center
Chicago, Illinois, United States
Rush-Riverside Cancer Center
Kankakee, Illinois, United States
Countries
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Other Identifiers
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RUSH-AML-9754
Identifier Type: -
Identifier Source: secondary_id
ALZA-RUSH-AML-9754
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1445
Identifier Type: -
Identifier Source: secondary_id
CDR0000066413
Identifier Type: -
Identifier Source: org_study_id