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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005802 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may help them kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-2 when given after chemotherapy and donor white blood cells and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Biological: aldesleukin Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cytarabine Drug: etoposide Drug: fludarabine phosphate Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: therapeutic hydrocortisone Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Chemotherapy (CT) Followed by Donor Lymphocyte Infusion (DLI) Plus Interleukin 2 (IL-2) for Patients With Relapse Acute Myeloid or Lymphoid Leukemia After Allogeneic Hematopoietic Transplant |
Study Start Date: | June 1999 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of interleukin-2 (IL-2). Patients are stratified according to disease status after chemotherapy (acute myeloid leukemia (AML) in complete remission (CR) vs acute lymphoid leukemia (ALL) or AML not in CR).
Patients receive one of three induction chemotherapy regimens, depending on type of leukemia, prior treatment, and response.
Patients receive one donor lymphocyte infusion IV over 15-30 minutes within 28-60 days after starting chemotherapy. On the same day, IL-2 IV is administered over 24 hours for 5 days. After 2 days rest, IL-2 is again administered continuously for 10 days.
Cohorts of 5 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 5 patients experience dose limiting toxicities. Up to 40 patients are treated at the MTD.
Patients are followed monthly for 3 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 11-15 patients per year will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed acute myeloid leukemia or acute lymphoid leukemia after allogeneic peripheral blood stem cell transplantation (PBSCT), documented by 1 of the following:
Morphologic relapse defined as 1 or more of the following:
Cytogenetic relapse defined as:
Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor
Current donor must be same as prior donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Mary E. D. Flowers, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000067777, FHCRC-1380.00, NCI-H00-0057 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005802 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia with t(8;21)(q22;q22) |
adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
Anti-Inflammatory Agents Acute Lymphoblastic Leukemia, Childhood Antimetabolites Leukemia, Lymphoid Hydrocortisone Immunologic Factors Leukemia, Myeloid, Acute Etoposide phosphate Leukemia Acute Myelocytic Leukemia Anti-Retroviral Agents Acute Myeloid Leukemia, Adult Methotrexate Analgesics Congenital Abnormalities |
Etoposide Cytarabine Acute Lymphoblastic Leukemia Anti-HIV Agents Precursor Cell Lymphoblastic Leukemia-Lymphoma Cortisol succinate Leukemia, Myeloid Fludarabine monophosphate Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Recurrence Folic Acid Acute Myeloid Leukemia, Childhood Aldesleukin |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Leukemia Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Abortifacient Agents |
Methotrexate Analgesics Dermatologic Agents Nucleic Acid Synthesis Inhibitors Cytarabine Anti-HIV Agents Neoplasms by Histologic Type Cortisol succinate Enzyme Inhibitors Fludarabine monophosphate Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |