A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 24
- Locations
- 1
Study 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 with myelodysplastic syndrome.
Detailed Description
OBJECTIVES:
- Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS).
- Evaluate the hematologic effects of subcutaneous IL-2 in MDS.
OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially.
Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued.
PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 120 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML)
- •No patients with refractory anemia with excess blasts in transformation (RAEB-t)
- •PATIENT CHARACTERISTICS:
- •15 and over
- •Performance status:
- •Karnofsky 70-100
- •Hematopoietic:
- •Platelet count greater than 20,000
- •Bilirubin less than 1.6 mg/dL
- •SGOT less than 150 U/L
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension
- •No significant pleural effusion, dyspnea at rest or severe exertional dyspnea
- •No patients with nephrotic syndrome
- •No uncontrolled infections or active peptic ulcer disease
- •No serious intercurrent medical illness
- •Not pregnant or nursing
- •Adequate contraception required of all patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunosuppressive therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •At least 2 weeks since corticosteroid therapy
- •At least 4 weeks since other endocrine therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •Not specified
Exclusion Criteria
- Not provided