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Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005802
  Purpose

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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy
Drug Information available for: Hydrocortisone acetate Hydrocortisone Methotrexate Cytarabine hydrochloride Fludarabine Etoposide Mitoxantrone Mitoxantrone hydrochloride Fludarabine monophosphate Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Interleukin-2 Aldesleukin Filgrastim Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1999
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of interleukin-2 following donor lymphocyte infusion and chemotherapy in patients with relapsed acute myeloid or lymphoid leukemia after allogeneic peripheral blood stem cell transplantation.
  • Determine the toxicity and efficacy of this regimen in these patients.

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.

  • Regimen 1: Patients receive high dose cytarabine IV over 2 hours twice a day on days 1, 3, and 5.
  • Regimen 2: Patients receive mitoxantrone IV over 15 minutes and etoposide IV over 30 minutes on days 1-5.
  • Regimen 3: Patients receive fludarabine IV over 30 minutes on days 1-5, cytarabine IV over 2 hours on days 1-4, and filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients with extramedullary relapse receive local radiotherapy. Patients with ALL or CNS relapse receive intrathecal methotrexate with or without hydrocortisone and cytarabine.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

      • Peripheral blasts in absence of growth factor therapy
      • Bone marrow blasts greater than 5% of nucleated cells
      • Extramedullary (CNS, testicular, or other sites)
    • Flow cytometric relapse defined as appearance in peripheral blood or bone marrow of cells with abnormal immunophenotype consistent with leukemia recurrence and noted at pretransplant
    • Cytogenetic relapse defined as:

      • Appearance in 1 or more metaphases from bone marrow or peripheral blood cells of nonconstitutional cytogenetic abnormality noted in at least 1 cytogenetic study performed prior to transplant OR
      • New abnormality known to be associated with leukemia
  • Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor

    • Must have achieved complete remission after PBSCT
  • Current donor must be same as prior donor

    • Age 10 and over

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No congestive heart failure requiring diuretics
  • No uncontrolled arrhythmia

Pulmonary:

  • No pulmonary dysfunction requiring oxygen therapy
  • No pneumonia or severe obstruction
  • FEV_1 at least 50% of predicted OR no greater than 50% decline from baseline
  • No severe restrictive lung disease (total lung capacity less than 60% or 50% declined from baseline) not due to leukemia

Other:

  • No sepsis, aspergillosis, or other active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent cyclosporine or tacrolimus during induction chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005802

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Mary E. D. Flowers, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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)

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009