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
- 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
PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
- 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)
- 15 and over
- Karnofsky 70-100
- 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
- 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:
- At least 4 weeks since prior immunosuppressive therapy
- At least 4 weeks since prior chemotherapy
- At least 2 weeks since corticosteroid therapy
- At least 4 weeks since other endocrine therapy
- At least 4 weeks since prior radiotherapy
- Not specified