|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.Related Publications
Bennett CL, Golub R, Waters TM, et al.: Economic analyses of phase III cooperative cancer group clinical trials: are they feasible? Cancer Invest 15 (3): 227-36, 1997.[PUBMED Abstract]
Bennett CL, Stinson TJ, Tallman MS, et al.: Economic analysis of a randomized placebo-controlled phase III study of granulocyte macrophage colony stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia. Eastern Cooperative Oncology Group (E1490). Ann Oncol 10 (2): 177-82, 1999.[PUBMED Abstract]
Bennett JM, Young ML, Andersen JW, et al.: Long-term survival in acute myeloid leukemia: the Eastern Cooperative Oncology Group experience. Cancer 80 (11 Suppl): 2205-9, 1997.[PUBMED Abstract]
Paietta E, Andersen J, Racevskis J, et al.: Significantly lower P-glycoprotein expression in acute promyelocytic leukemia than in other types of acute myeloid leukemia: immunological, molecular and functional analyses. Leukemia 8 (6): 968-73, 1994.[PUBMED Abstract]
Paietta E, Andersen J, Rowe J, et al.: Myeloid blast cell maturation determines response in adult de novo acute myeloid leukemia (AML): a response-driven antigen expression analysis in 382 Eastern Cooperative Oncology Group (ECOG) patients. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-47, 86, 1995.
Paietta E, Andersen J, Yunis J, et al.: Acute myeloid leukaemia expressing the leucocyte integrin CD11b-a new leukaemic syndrome with poor prognosis: result of an ECOG database analysis. Eastern Cooperative Oncology Group. Br J Haematol 100 (2): 265-72, 1998.[PUBMED Abstract]
Paietta E, Goloubeva O, Bennett JM, et al.: A surrogate marker profile for acute promyelocytic leukemia (APL) and the association of immunophenotypic markers with morphologic and molecular subtypes of APL. [Abstract] Blood 100 (11 pt 2): A-4434, 2002.
Paietta E, Goloubeva O, Neuberg D, et al.: A surrogate marker profile for PML/RAR alpha expressing acute promyelocytic leukemia and the association of immunophenotypic markers with morphologic and molecular subtypes. Cytometry B Clin Cytom 59B (1): 1-9, 2004.[PUBMED Abstract]
Paietta EM, Andersen J, Yunis JJ, et al.: Immature acute monocytic leukemia (AMOL): blast cells expressing the interleukin-2 receptor b-chain and the stem cell factor receptor identify a new prognosis leukemic syndrome: an ECOG database study. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A1057, 1996.
Paietta EM, Neuberg D, Rowe JM, et al.: The prognostic significance of immuneprofiles in adult acute myeloid leukemia (AML) varies with age: a comparative analysis of the Eastern Cooperative Oncology Group (ECOG) database. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A13, 5a, 1997.
Paietta E, Racevskis J, Bennett JM, et al.: Biologic heterogeneity in Philadelphia chromosome-positive acute leukemia with myeloid morphology: the Eastern Cooperative Oncology Group experience. Leukemia 12 (12): 1881-5, 1998.[PUBMED Abstract]
Rowe JM: Use of growth factors during induction therapy for acute myeloid leukemia. Leukemia 10 (Suppl 1): S40-3, 1996.[PUBMED Abstract]
Rowe JM, Kim HT, Cassileth PA, et al.: Time to complete remission is not a significant prognostic factor in AML: a report on 1,959 consecutive patients registered to 6 studies of the Eastern Cooperative Oncology Group (ECOG). [Abstract] Blood 104 (11): A-862, 2004.
Rowe JM, Kim HT, Cassileth PA, et al.: Adult patients with acute myeloid leukemia who achieve complete remission after 1 or 2 cycles of induction have a similar prognosis: a report on 1980 patients registered to 6 studies conducted by the Eastern Cooperative Oncology Group. Cancer 116 (21): 5012-21, 2010.[PUBMED Abstract]
Rowe JM, Young M, Cassileth PA, et al.: Induction and post-remission therapy in acute myeloid leukemia: experience of the Eastern Cooperative Oncology Group (ECOG). In: Hiddemann W: Acute Leukemia VII: Experimental Approaches and Novel Therapies. Springer: New York, 1998, pp. 693-699.
Tallman MS, Neuberg D, Bennett JM, et al.: Acute megakaryocytic leukemia: the Eastern Cooperative Oncology Group experience. Blood 96 (7): 2405-11, 2000.[PUBMED Abstract]
Trial Lead Organizations
Eastern Cooperative Oncology Group
|Jacob Rowe, MD, Protocol chair (Contact information may not be current)|
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.