Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

• ClinicalTrials.gov Identifier: NCT00002746
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: February 27, 2019
• Sponsor: University of Washington
• Information provided by (Responsible Party): University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms	Biological: aldesleukin	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
• Study Start Date: January 1996
• Actual Primary Completion Date: April 2004
• Actual Study Completion Date: April 2004

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 120 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Washington

University of Washington Medical Center

Seattle, Washington, United States, 98195-6043

Sponsors and Collaborators

University of Washington

Investigators

• Study Chair: John A. Thompson, MD; Seattle Cancer Care Alliance

More Information

• Responsible Party: University of Washington
• ClinicalTrials.gov Identifier: NCT00002746
• Other Study ID Numbers: 10469; UW-26-245-B; NCI-V96-0848
• First Posted: January 27, 2003
• Last Update Posted: February 27, 2019
• Last Verified: February 2019

Keywords provided by University of Washington:

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

Additional relevant MeSH terms:

Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome; Disease; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Aldesleukin; Antineoplastic Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents