Vorinostat and Alvocidib in Treating Patients With Advanced Solid Tumors
Part of paid clinical trials in New York, New York.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00324480
- Phase
- PHASE1
- Status
- Completed
Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- alvocidib — DRUGGiven IV
- vorinostat — DRUGGiven orally
- pharmacological study — OTHERCorrelative studies
Study Details
This phase I trial is studying the side effects and best dose of vorinostat when given together with alvocidib in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as vorinostat and alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with alvocidib may kill more tumor cells.
Key Dates
- Start date
- Mar 31, 2006
- Status verified
- Oct 2011
- Primary completion
- Apr 30, 2009
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (chemotherapy, enzyme inhibitor)Before beginning course 1 of study therapy, patients receive oral SAHA on days 1-3 in order to ensure tolerability of the drug. Beginning 1 week later, patients receive oral SAHA once daily on days 1-3 and 8-10 and fixed-dose alvocidib IV over 1 hour on days 2 and 9. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Maximum tolerated dose of vorinostat when administered in combination with a fixed dose of weekly flavopiridol [ Time Frame: Course 1 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | - |
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