Interleukin-2 Following Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2000-06-30

Brief Summary

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RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse.

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Detailed Description

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OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of interleukin-2 following allogeneic T-cell depleted bone marrow transplant in patients with hematologic malignancies at high risk of relapse. II. Determine the optimal dose of interleukin-2 in this regimen which will result in maximal natural killer cell and lymphokine activated killer cell activity in vitro.

OUTLINE: This is a dose escalation study. Patients receive CD34+ stem cell augmented donor bone marrow on day 0 on another protocol. Patients then receive interleukin-2 (IL-2) subcutaneously on day 30. Treatment continues for 12 weeks in the absence of dose limiting toxicity. Cohorts of 4 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose prior to that which causes at least grade 3 toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.

Conditions

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Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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aldesleukin

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 0.5 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characterisitics Hepatic: Bilirubin less than 2.5 mg/dL (unless Gilbert's syndrome present) Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within past 12 months Pulmonary: No requirement for oxygen Other: Afebrile for greater than 48 hours No active, serious infection (e.g., sepsis, mucormycosis, or uncontrolled aspergillosis) No debilitating medical or psychiatric illness that would preclude compliance Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No