Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425477 |
RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia.
PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF works in treating patients with MDS or acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: bexarotene Drug: sargramostim Procedure: biopsy Procedure: cytogenetic analysis Procedure: flow cytometry Procedure: fluorescence in situ hybridization Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bexarotene + Sargromastastin as Agents of Differentiation in MDS and AML |
Estimated Enrollment: | 18 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral bexarotene and sargramostim (GM-CSF) subcutaneously on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples are collected at baseline and after 1 or 2 courses of study therapy. Samples are examined by flow cytometry for laboratory studies, including biological markers, and by fluorescent in situ hybridization (FISH) for cytogenetic changes.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis (confirmed by bone marrow aspirate and/or biopsy) of 1 of the following:
Myelodysplastic syndromes of 1 of the following cell types:
Relapsed or refractory acute myeloid leukemia (AML), meeting 1 of the following criteria:
Not otherwise categorized, including any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior treatment for myeloid disorder, including any of the following:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | B. Douglas Smith, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000525989, JHOC-J0675, JHOC-NA_00003076 |
Study First Received: | January 19, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00425477 |
Health Authority: | Unspecified |
refractory anemia with excess blasts recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable refractory anemia with ringed sideroblasts refractory cytopenia with multilineage dysplasia chronic myelomonocytic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult pure erythroid leukemia (M6b) adult erythroleukemia (M6a) adult acute megakaryoblastic leukemia (M7) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with inv(16)(p13;q22) |
Leukemia, Monocytic, Acute Precancerous Conditions Chronic myelomonocytic leukemia Refractory anemia Acute myelomonocytic leukemia Di Guglielmo's syndrome Leukemia, Myeloid, Acute Leukemia Preleukemia Anemia, Refractory Bexarotene Neoplasm Metastasis Acute erythroblastic leukemia Acute myeloid leukemia, adult Congenital Abnormalities |
Acute myelocytic leukemia Myelodysplastic syndromes Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplasia Anemia Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Myelodysplastic myeloproliferative disease Leukemia, Erythroblastic, Acute Anemia, Refractory, with Excess of Blasts |
Anticarcinogenic Agents Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Syndrome Physiological Effects of Drugs Protective Agents Pharmacologic Actions |