Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cortisol succinate; Cytarabine; Etoposide; Fludarabine; Fludarabine phosphate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Interleukin-2; Methotrexate; Mitoxantrone

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