Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Lymphoma
- Sponsor
- University of Washington
- Enrollment
- 30
- Locations
- 1
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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 in treating patients who have mycosis fungoides.
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides. * Determine the response rate of patients treated with this regimen. * Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients. OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses. Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD. Patients are followed at least 3 times during year 1 and then annually thereafter. PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified