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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00534469 |
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them.
After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy and radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant.
PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.
Condition | Intervention | Phase |
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Leukemia |
Biological: aldesleukin Biological: filgrastim Drug: busulfan Drug: cytarabine Drug: etoposide Drug: idarubicin Procedure: autologous hematopoietic stem cell transplantation Procedure: bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients </=60 Years of Age Using Busulfan/Fractionated Total Body Irradiation (FTBI) and VP16 as the Preparative Regimen |
Estimated Enrollment: | 50 |
Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE:
Patients who have not received prior consolidation therapy receive high-dose cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin* IV over 5-10 minutes on days 1-3. NOTE: *Patients with good risk cytogenetics t(8;21), inv(16), or t(16;16) or patients who received > 200 mg/m² of anthracycline do not receive idarubicin.
Patients receive G-CSF IV or SC daily beginning on day 5 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML)
FAB types M0-2 and M4-M7
In first complete hematological remission as confirmed by marrow aspiration and biopsy
In complete remission for less than 6 months
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent use the following medications during aldesleukin therapy :
Study ID Numbers: | CDR0000564772, CHNMC-99040 |
Study First Received: | September 20, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00534469 History of Changes |
Health Authority: | United States: Federal Government |
adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (M6a) |
adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) |
Leukemia, Monocytic, Acute Antimetabolites Immunologic Factors Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Etoposide phosphate Anti-Bacterial Agents Leukemia Acute Erythroblastic Leukemia Acute Myelocytic Leukemia Anti-Retroviral Agents Acute Myeloid Leukemia, Adult Congenital Abnormalities Etoposide |
Alkylating Agents Cytarabine Anti-HIV Agents Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Leukemia, Myelomonocytic, Acute Idarubicin Leukemia, Erythroblastic, Acute Aldesleukin Busulfan Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Di Guglielmo's Syndrome |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Leukemia Anti-Retroviral Agents Therapeutic Uses Etoposide Alkylating Agents |
Cytarabine Anti-HIV Agents Neoplasms by Histologic Type Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Idarubicin Neoplasms Aldesleukin Busulfan Myeloablative Agonists Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic |