Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (NCT00425477) | Clinical Trial Compass
CompletedPhase 2
Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
United States26 participantsStarted 2006-11
Plain-language 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 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.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ne…
What they're measuring
1
Clinical Response (Complete and Partial)
Timeframe: assessed after 2 cycles, up to 2 years
Trial details
NCT IDNCT00425477
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins