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Sponsored by: |
University of Washington |
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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 |
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 |
Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
Study ID Numbers: | CDR0000064671, UW-26-245-B, NCI-V96-0848 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002746 |
Health Authority: | United States: Federal Government |
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 myelodysplastic/myeloproliferative disease, unclassifiable childhood myelodysplastic syndromes |
Myelodysplastic syndromes Chronic myelogenous leukemia Precancerous Conditions Chronic myelomonocytic leukemia Refractory anemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders Anemia |
Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia Preleukemia Aldesleukin Anemia, Refractory Interleukin-2 Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Disease Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions Neoplasms |
Pathologic Processes Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Syndrome Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |