Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms | Biological: aldesleukin | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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) |
| Enrollment: | 24 |
| Study Start Date: | January 1996 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002746
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
More Information
| Responsible Party: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00002746 History of Changes |
| Other Study ID Numbers: |
CDR0000064671 UW-26-245-B NCI-V96-0848 |
| First Submitted: | November 1, 1999 |
| First Posted: | January 27, 2003 |
| Last Update Posted: | December 13, 2012 |
| Last Verified: | December 2012 |
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:
|
Syndrome Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Aldesleukin Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |