Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia
Part of paid clinical trials in Richmond, Virginia.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00278330
- Phase
- PHASE1
- Status
- Completed
Conditions
- Blastic Phase Chronic Myelogenous Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Refractory Anemia With Excess Blasts
- Relapsing Chronic Myelogenous Leukemia
- Untreated Adult Acute Lymphoblastic Leukemia
- Untreated Adult Acute Myeloid Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- alvocidib — DRUGGiven by infusion
- vorinostat — DRUGGiven orally
Study Details
This phase I trial is studying the side effects and best dose of flavopiridol when given together with vorinostat in treating patients with relapsed or refractory acute leukemia or chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving flavopiridol together with vorinostat may be an effective treatment for leukemia or refractory anemia.
Key Dates
- Start date
- Jan 31, 2006
- Status verified
- Apr 2013
- Primary completion
- Oct 31, 2009
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm IPatients will receive a 1-hour infusion of flavopiridol on 5 days in week 1 and vorinostat by mouth three times a day in weeks 1 and 2. Treatment may repeat every 3 weeks for as long as benefit is shown.
Primary Outcome Measure
MTD for the combination of alvocidib and vorinostat, assessed by Common Toxicity Criteria version 3.0 [ Time Frame: 21 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | - |
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