Status:
COMPLETED
Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Assess the clinical response in patients with myelodysplastic syndromes or acute myeloid leukemia treated with bexarotene and sargramostim (GM-CSF). Secondary * Determine the...
Eligibility Criteria
Inclusion
- 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:
- Refractory anemia (RA) with ringed sideroblasts
- Refractory cytopenia with multilineage dysplasia (RCMD)
- RCMD and ringed sideroblasts
- RA with excess blasts-1
- RA with excess blasts-2
- Myelodysplastic syndromes, unclassified
- Chronic myelomonocytic leukemia
- Relapsed or refractory acute myeloid leukemia (AML), meeting 1 of the following criteria:
- Recurrent genetic abnormalities (11q23 \[MLL\] abnormalities)
- Multilineage dysplasia
- Therapy-related AML
- Not otherwise categorized, including any of the following:
- M0 minimally differentiated
- M1 without maturation
- M2 with maturation
- M4 myelomonocytic leukemia
- M5 monoblastic/monocytic leukemia
- M6 erythroid leukemia
- M7 megakaryoblastic leukemia
- Newly diagnosed untreated AML allowed provided patient does not qualify for or refused potentially curative intensive chemotherapeutic regimens
- No RA with 5q-syndrome
- No peripheral leukemia with blast count \> 30,000/mm³ (uncontrolled with hydroxyurea)
- Relatively stable bone marrow function for \> 7 days (i.e., no WBC doubling to \> 10,000/mm\^3)
- No acute promyelocytic leukemia
- No clinical symptoms of active CNS disease (if CNS disease is suspected, patient must have lumbar puncture with negative cytology)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 1.6 mg/dL (unless secondary to hemolysis)
- AST and ALT ≤ 4 times upper limit of normal (unless disease related)
- Hemoglobin ≥ 8 g/dL (transfusions allowed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No untreated positive blood cultures or progressive infection as assessed by radiographic studies
- No history of intolerance to sargramostim (GM-CSF)
- PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- At least 2 weeks since prior treatment for myeloid disorder, including any of the following:
- Chemotherapy
- Hematopoietic growth factors
- Biologic therapy (e.g., monoclonal antibodies)
- Hydroxyurea for patients with WBC \> 10,000/mm\^3 allowed
- No concurrent vitamin A supplementation
- No concurrent gemfibrozil
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00425477
Start Date
November 1 2006
End Date
September 30 2016
Last Update
October 5 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410