Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002746
• Other study ID #: 10469
• Secondary ID: UW-26-245-BNCI-V
• Status: Completed
• Phase: Phase 1
• Start date: January 1996
• Est. completion date: April 2004

Study information

• Verified date: February 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States,