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Sponsored by: |
University of Washington |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002746 |
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 Diseases |
Drug: aldesleukin |
Phase I |
MedlinePlus related topics: | Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
ChemIDplus related topics: | Aldesleukin Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS) |
Estimated Enrollment: | 24 |
Study Start Date: | January 1996 |
OBJECTIVES:
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Washington | |||||
University of Washington Medical Center | |||||
Seattle, Washington, United States, 98195-6043 |
University of Washington |
Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000064671, UW-26-245-B, NCI-V96-0848 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002746 |
Health Authority: | United States: Federal Government |
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