17
Participants
Start Date
September 30, 2008
Primary Completion Date
November 30, 2010
Study Completion Date
December 31, 2010
VEGF inhibitor PTC299
20 mg capsules to be taken by mouth BID. Three dose levels will be evaluated: 40 mg, 80mg, and 100mg BID. Subjects will receive PTC299 in consecutive 28-day cycles for a maximum of 12 cycles.
gene expression analysis
To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS tumor biopsies using real-time QPCR-based profiling.
polymerase chain reaction
To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS tumor biopsies using real-time QPCR-based profiling.
protein expression analysis
To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS tumor biopsies using real-time QPCR-based profiling.
immunohistochemistry staining method
To describe the effects of PTC299 on KS tumor biopsies with respect to expression of VEGF, the VEGFR-2 and -3, phospho-Akt, p53, HIF-1α and proliferation, measured by Ki-67 staining.
laboratory biomarker analysis
To describe the effects of PTC299 on KS tumor biopsies with respect to expression of VEGF, the VEGFR-2 and -3, phospho-Akt, p53, HIF-1α and proliferation, measured by Ki-67 staining.
pharmacological study
To describe the pharmacokinetics of PTC299 in patients with HIV-associated KS. To describe the effects of PTC299 on circulating VEGF, VEGFR and cytokine levels in patients with HIV-associated KS.
biopsy
To describe the effects of PTC299 on KS tumor biopsies with respect to expression of VEGF, the VEGFR-2 and -3, phospho-Akt, p53, HIF-1α and proliferation, measured by Ki-67 staining.
Memorial Sloan-Kettering Cancer Center, New York
Cancer Research Center of Hawaii, Honolulu
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle
Rebecca and John Moores UCSD Cancer Center, La Jolla
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles
Beth Israel Deaconess Medical Center, Boston
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus
Collaborators (1)
National Cancer Institute (NCI)
NIH
PTC Therapeutics
INDUSTRY
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK