Kaposi Sarcoma – NCI-09-C-0130
Dr. Robert Yarchoan
Principal Investigator
NCI's Center for Cancer Research (CCR) is currently conducting the following trial for patients with Kaposi 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.
- Patients receive bevacizumab IV over 90 minutes on Days 1 and 8 and pegylated liposomal doxorubicin hydrochloride IV over 30 minutes on Day 8 of Course 1
- Beginning in Course 2 and all subsequent courses, patients receive bevacizumab IV over 90 minutes followed by pegylated liposomal doxorubicin hydrochloride IV over 30 minutes on Day 1
- Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
- Patients with stable disease or better will proceed to maintenance therapy
- Patients receive bevacizumab IV over 90 minutes on Day 1
- Treatment repeats every 3 weeks for 11 courses in the absence of disease progression or unacceptable toxicity
- Patients undergo blood sample collection periodically for analysis of HIV viral load levels, lymphocyte phenotype TBNK, and KSHV viral load levels; patients also undergo saliva sample collection periodically for analysis of KSHV viral load levels
- After completion of study therapy, patients are followed at 4 weeks and then every 3 months for up to 2 years
Why is this trial important?
Kaposi sarcoma (KS) is a rare tumor with increased incidence in several special populations: patients with HIV, transplant patients, and elderly patients infected with the virus, Kaposi sarcoma-associated herpesvirus. The current standard of care in advanced KS includes the use of liposomal doxorubicin (or liposomal daunorubicin). In a subset of patients, treatment requires long-term use of liposomal anthracyclines beyond the maximum recommended cumulative dose. Furthermore, while liposomal doxorubicin is generally effective, patients with advanced disease, especially when there is pulmonary involvement, may have poor outcome with liposomal doxorubicin alone. This trial builds on the previous studies in KS performed by the HIV and AIDS Malignancy branch by combining an anti-angiogenic agent, bevacizumab, with liposomal doxorubicin, followed by bevacizumab alone. By only using liposomal doxorubicin for a limited time, this regimen would be anthracycline-sparing as compared to treatment with just liposomal doxorubicin. We are testing the hypothesis that this regimen will be will tolerated and may be more active in patients with advanced KS than liposomal doxorubicin alone.
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