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Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

15 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 25, 2019
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00002746
Brief Title
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
Official Title
A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Thompson, MD
Organizational Affiliation
Seattle Cancer Care Alliance
Official's Role
Study Chair
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States

12. IPD Sharing Statement

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Interleukin-2 in Treating Patients With Myelodysplastic Syndrome

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