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Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Patients With Myelodysplastic Syndrome  Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
For Condition: atypical chronic myeloid leukemia,Chronic Myelomonocytic Leukemia,myelodysplastic and myeloproliferative disease,Myelodysplastic Syndromes
Status: No longer recruiting
Sponsor(s): University of Washington ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnThompson, Study Chair, Seattle Cancer Care Alliance
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
Additional Information:
Study ID Numbers: CDR0000064671; UW-26-245-B,NCI-V96-0848
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002746
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
2. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
3. PTK787/ZK 222584 in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
4. Paricalcitol in Treating Patients With Myelodysplastic Syndrome
5. Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
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