NCT00002746

Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 15 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin

Timeline

• Start date: 1996-01-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2003-01-27
• Last updated: 2019-02-27

Locations

1 site across 1 country: United States