Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

NCT00002746 | Completed Phase 1

• 3 other identifiers: 10469UW-26-245-BNCI-V96-0848
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Keywords

refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; childhood myelodysplastic syndromes

Interventions

aldesleukin BIOLOGICAL

Eligibility Criteria

• Age: 15 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Myeloproliferative Disorders

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John A. Thompson, MD

  Seattle Cancer Care Alliance

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1996
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

US (1)