A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
aldesleukin
Anemia+16
+ Bone Marrow Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: January 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 15 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Washington Medical Center
Seattle, United StatesOpen University of Washington Medical Center in Google Maps