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Clinical Trials (PDQ®)

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Clinical Trials (PDQ®)

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
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted55 to 70NCIEST-1490

Objectives

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.

Entry Criteria

Disease Characteristics:


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


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Prior corticosteroid therapy allowed

Radiotherapy:
  Not specified

Surgery:
  Not applicable


Patient Characteristics:


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


Expected Enrollment

110 patients will be entered over approximately 1 year.

Outline

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, Tallman MS, et al.: Economic analysis of GM-CSF as adjuvant therapy for adults with AML. [Abstract] Blood 88 (10 suppl 1): A-825, 209a, 1996.

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 (ECOG) experience. [Abstract] Blood 94 (10 suppl 1, pt 1): A-2656, 596a, 1999.

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 Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Jacob Rowe, MD, Protocol chair (Contact information may not be current)
Ph: 585-275-5345

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.

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