Dasatinib and Vorinostat in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT00816283
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- dasatinib — DRUG50 mg orally 2 times per day or 140 mg orally one time per day
- vorinostat — DRUG100 mg orally 2 times per day
- cytogenetic analysis — GENETICPerformed at the end of cycle two of treatment and every six cycles for patients with accelerated CML and every 3 cycles for patients with blast crisis or Ph+ ALL
- gene expression analysis — GENETICBone marrow aspirate obtained pre-treatment, at first scheduled bone marrow assay and at relapse. Peripheral blood drawn pre-therapy, day +14 of first treatment cycle and at relapse.
- mutation analysis — GENETICPerformed at baseline and at every bone marrow analysis on peripheral blood
- reverse transcriptase-polymerase chain reaction — GENETICPeripheral blood drawn prior to starting Vorinostat on Day 1 and on Day 14 of treatment
- flow cytometry — OTHERPerformed at the end of cycle two of treatment and every six cycles for patients with accelerated CML and every 3 cycles for patients with blast crisis or Ph+ ALL
- laboratory biomarker analysis — OTHERPerformed pre-treatment and day +14 of treatment
Study Details
RATIONALE: Dasatinib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving dasatinib together with vorinostat may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib when given together with vorinostat in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or acute lymphoblastic leukemia.
Key Dates
- Start date
- Sep 30, 2008
- Status verified
- Jul 2012
- Primary completion
- Jun 30, 2011
- Completion
- Jun 30, 2011
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Maximum tolerated dose [ Time Frame: 21 days after the beginning of treatment ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | - |
| City of Hope Medical Group | Pasadena | California | 91105 | - |
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