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 — DRUG
    Given IV
  • vorinostat — DRUG
    Given orally
  • pharmacological study — OTHER
    Correlative 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)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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