Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Intervention / Treatment
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* Biological: aldesleukin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes