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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005962 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia.
PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Biological: sargramostim Drug: cyclophosphamide Drug: cytarabine Drug: gemtuzumab ozogamicin Drug: liposomal daunorubicin citrate Drug: topotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by disease status (relapse less than 6 months after first complete response (CR) vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) vs second or greater relapse).
Induction: Patients are randomized to 1 of 3 treatment arms:
Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until death.
PROJECTED ACCRUAL: A maximum of 150-165 patients (50-55 per arm) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven acute myelogenous leukemia of one of the following types:
Must meet 1 of the following criteria:
Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Mark R. Litzow, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067944, E-4999 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005962 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult acute myeloid leukemia adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) |
adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute megakaryoblastic leukemia (M7) adult acute monocytic leukemia (M5b) adult acute minimally differentiated myeloid leukemia (M0) |
Antimetabolites Leukemia, Monocytic, Acute Daunorubicin Immunologic Factors Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Cyclophosphamide Leukemia, Myeloid, Acute Anti-Bacterial Agents Leukemia Acute Erythroblastic Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute Alkylating Agents |
Cytarabine Citric Acid Leukemia, Myeloid Gemtuzumab Antiviral Agents Immunosuppressive Agents Recurrence Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Antineoplastic Agents, Alkylating Topotecan Antirheumatic Agents Acute Promyelocytic Leukemia Di Guglielmo's Syndrome |
Antimetabolites Daunorubicin Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Leukemia Therapeutic Uses Alkylating Agents |
Cytarabine Neoplasms by Histologic Type Enzyme Inhibitors Leukemia, Myeloid Gemtuzumab Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Topotecan Antirheumatic Agents |