Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)

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.

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.

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:

Age:

• 15 and over

Performance status:

• Karnofsky 70-100

Hematopoietic:

• Platelet count greater than 20,000

Hepatic:

• Bilirubin less than 1.6 mg/dL
• SGOT less than 150 U/L

Renal:

• 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

Pulmonary:

• No significant pleural effusion, dyspnea at rest or severe exertional dyspnea

Other:

• 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

Surgery:

• Not specified