AIDS Related Cancers – NCI-06-C-0083
Dr. Robert Yarchoan
Principal Investigator
NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with Kaposi's sarcoma. Click on the trial below for additional details, including a summary of primary eligibility, study outline, and information on how to contact Dr. Yarchoan and his staff directly.
You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.
This is a dose-escalation, parallel group study.
- Patients are stratified according to concurrent ritonavir treatment (yes vs. no) and HIV-related Kaposi's sarcoma (KS) (yes vs. no)
- Patients receive oral sorafenib once or twice daily on Days 1 through 21
- Treatment repeats every 21 days for up to 18 courses (54 weeks) in the absence of disease progression or unacceptable toxicity
- Groups of 6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose is determined
- After completion of study therapy, patients are followed for 3 to 6 weeks
Why is this trial important?
At the present time, systemic chemotherapy for Kaposi's sarcoma usually involves cytotoxic chemotherapy drugs that have short-term and cumulative toxicities. As a result, novel targeted therapies are urgently needed. This trial is exploring a novel targeted therapy that blocks several specific pathways believed to be important in the formation and growth of Kaposi's sarcoma. BAY 43-9006 (also called sorafenib) blocks both mutant and wild-type c-Raf kinase, which is important in the formation of many tumors. This drug was recently approved for patients with advanced kidney cancer, and there is thus substantial human experience with the agent. BAY 43-9006 blocks several receptors that appear to be particularly important in Kaposi's sarcoma, including a special form of the receptor for vascular endothelial growth factor (VEGF-R3).
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