Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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 |
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| 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 |
More Information
Additional Information:
No publications provided by Fred Hutchinson Cancer Research Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00005802 History of Changes |
| Other Study ID Numbers: | 1380.00, FHCRC-1380.00, NCI-H00-0057, CDR0000067777 |
| Study First Received: | June 2, 2000 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Methotrexate Fludarabine monophosphate Vidarabine Aldesleukin Fludarabine Etoposide |
Interleukin-2 Mitoxantrone Lenograstim Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Hydrocortisone-17-butyrate Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents |
ClinicalTrials.gov processed this record on June 18, 2013