Phase III Randomized Double-Blind Trial of GM-CSF vs Placebo Following DNM/ARA-C Induction and High-Dose ARA-C Consolidation in Elderly Patients with AML
Basic Trial Information
|Phase III||Treatment||Completed||55 to 70||NCI||EST-1490|
I. Evaluate the safety and efficacy of recombinant human granulocyte/macrophage colony stimulating factor (GM-CSF) administered as a daily 4-hour infusion following induction chemotherapy with daunomycin/cytosine arabinoside and following consolidation with high-dose cytosine arabinoside in elderly patients with de novo AML. II. Evaluate the ability of GM-CSF to accelerate hematopoietic recovery following induction and consolidation chemotherapy in elderly patients with AML. III. Assess whether GM-CSF decreases the morbidity and mortality from infectious complications following induction and consolidation chemotherapy in elderly patients with de novo AML. IV. Estimate the rate and duration of CR and survival duration of elderly patients with de novo AML who receive induction chemotherapy with daunomycin/cytosine arabinoside and a single course of consolidation chemotherapy with high-dose cytosine arabinoside.
Acute myeloid leukemia morphologically proven from bone marrow aspirate, smears, or touch preps of marrow biopsy Pathology review at the ECOG required Concurrent registration on EST-1485 (Antigenic Surface Markers, Karyotypes, and Bone Marrow Biopsies in Acute and Chronic Leukemias and Myodysplasias) required FAB types M1-7, i.e.: Acute myeloblastic leukemia (M1-2) Acute promyelocytic leukemia (M3) Acute myelomonocytic leukemia (M4) Acute monocytic leukemia (M5) Acute erythroleukemia (M6) Acute megakaryocytic leukemia (M7) No CML in blastic transformation No history of myelodysplasia
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior corticosteroid therapy allowed Radiotherapy: Not specified Surgery: Not applicable
Age: 55 to 70 Performance status: Not specified Hematopoietic: Not specified Hepatic: (obtained within 2 weeks of entry) Bilirubin no greater than 2.0 mg/dl Renal: (obtained within 2 weeks of entry) Creatinine less than 2.0 mg/dl Cardiovascular: Ejection fraction normal by institutional standards No severe concurrent cardiac disease Other: No prior malignancy for which chemotherapy or radiotherapy was given
110 patients will be entered over approximately 1 year.
Randomized double-blinded study. Patients with leukemic meningitis at entry receive treatment on Regimen A. Arm I. Induction: 2-Drug Combination Chemotherapy followed by Hematologic Toxicity Attenuation. Daunorubicin, Daunomycin, DNM, NSC-82151; Cytarabine, Cytosine arabinoside, ARA-C, NSC-63878; followed by Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (S. cerevisiae) (Hoechst-Roussel), GM-CSF, NSC-613795. Consolidation: Single-agent Chemotherapy followed by Hematologic Toxicity Attenuation. ARA-C; followed by GM-CSF. Arm II. Induction: 2-Drug Combination Chemotherapy followed by Placebo Therapy. DNM; ARA-C; followed by Placebo. Consolidation: Single-agent Chemotherapy followed by Placebo Therapy. ARA-C; followed by Placebo. Regimen A: Single-agent Intrathecal Chemotherapy with Leucovorin Rescue. Methotrexate, MTX, NSC-740; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590.
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Trial Contact Information
Trial Lead Organizations
Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.