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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070174 |
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: asparaginase Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: gemtuzumab ozogamicin Drug: methotrexate Drug: mitoxantrone hydrochloride Procedure: allogeneic bone marrow transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study |
Study Start Date: | December 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed primary acute myeloid leukemia (AML)
Meets the customary FAB criteria for AML
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Janet Franklin, MD, MPH | Children's Hospital Los Angeles |
Study ID Numbers: | CDR0000330133, COG-AAML03P1 |
Study First Received: | October 3, 2003 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00070174 |
Health Authority: | United States: Federal Government |
untreated childhood acute myeloid leukemia and other myeloid malignancies childhood acute monocytic leukemia (M5b) childhood acute megakaryocytic leukemia (M7) childhood acute minimally differentiated myeloid leukemia (M0) childhood acute myeloblastic leukemia with maturation (M2) |
childhood acute myeloblastic leukemia without maturation (M1) childhood acute myelomonocytic leukemia (M4) childhood acute monoblastic leukemia (M5a) childhood acute erythroleukemia (M6) |
Leukemia, Monocytic, Acute Daunorubicin Cyclosporine Clotrimazole Miconazole Acute myelomonocytic leukemia Cyclophosphamide Di Guglielmo's syndrome Leukemia, Myeloid, Acute Etoposide phosphate Cyclosporins Antibodies, Monoclonal Leukemia Methotrexate Acute erythroblastic leukemia |
Acute myelocytic leukemia Etoposide Cytarabine Immunoglobulins Asparaginase Tioconazole Acute myelogenous leukemia Myeloproliferative Disorders Leukemia, Myeloid Gemtuzumab Folic Acid Leukemia, Myelomonocytic, Acute Antibodies Leukemia, Erythroblastic, Acute Busulfan |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibiotics, Antineoplastic Sensory System Agents Therapeutic Uses Antifungal Agents Abortifacient Agents Analgesics Alkylating Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents |