Lymphoma Clinical Trial
Official title:
Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse
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.
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.
;
Primary Purpose: Treatment
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