Expired Study
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Seattle, Washington 98195


Purpose:

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.


Study summary:

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.


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: 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


NCT ID:

NCT00002746


Primary Contact:

Study Chair
John A. Thompson, MD
Seattle Cancer Care Alliance


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 17, 2017

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