Pomalidomide for Kaposi Sarcoma in People With or Without HIV
- Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma may be associated with human immunodeficiency virus (HIV) infection, researchers want to test the drug in people with and without HIV infection.
- To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with or without HIV.
- Individuals at least 18 years of age who have Kaposi sarcoma.
- Participants may or may not have HIV infection.
- Potential participants will be screened with a medical history and physical exam. Blood and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of a Kaposi sarcoma lesion may be performed if one has not already been done. Other imaging studies may be performed if needed.
- Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week break. These 28 days are one cycle of treatment.
- Participants will have up six cycles of treatment, unless the lesions completely resolve sooner. If there are signs of improvement after six cycles but the lesions are not completely gone, up to another six cycles of treatment may be given.
- Treatment will be monitored with frequent blood tests and other studies including photograph and other imaging of skin lesions.
- Participants will have regular follow-up visits for 5 years after stopping treatment....
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of the Safety, Pharmacokinetics and Efficacy of Pomalidomide (CC-4047) in the Treatment of Kaposi Sarcoma in Individuals With or Without HIV|
- Assess the safety, tolerability and pharmacokinetics of pomalidomide in subjects with Kaposi sarcoma, whether HIV associated or not, at a dose derived from solid tumor studies. [ Time Frame: 6 -12 months ] [ Designated as safety issue: Yes ]
- Explore antitumor affect of pomalidomide [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
- Assess variation in pharmacokinetics in relation to antiretroviral agent [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Assess changes in quality of life of participants [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week break. These 28 days are one cycle of treatment.
5 mg p.o. for 21 of 28 days
Kaposi Sarcoma (KS) is an incurable, multicentric angioproliferative tumor that most frequently involves the skin. It is seen most frequently in people with HIV or other forms of immune compromise. Current therapies are limited by toxicities, including cumulative cardiotoxicity, while effective oral agents, agents deliverable in resource-limited settings, and agents deliverable long-term for relapsing disease are all lacking.
The primary objective of this study is to:
Assess the safety, tolerability and pharmacokinetics of pomalidomide in subjects with Kaposi sarcoma, whether HIV associated or not.
- Age greater than or equal to 18 years
- Measurable, pathologically confirmed KS
- Any HIV status; HIV-associated KS subjects must be receiving and able to comply with HAART and have achieved an HIV viral load <10,000 copies/mL
- Hematologic and biochemical parameters within prespecified limits at baseline
- Willing to use effective birth control, as defined in the full protocol
- For subjects enrolled in the anti-tumor activity assessment phase, if KS is HIV-associated it must be increasing despite HAART and HIV suppression for greater than or equal to 2 months, or stable despite HAART for greater than or equal to 3 months
- No symptomatic pulmonary or visceral KS
- No specific KS therapy within 4 weeks (6 weeks if that therapy was bevacizumab)
- Neither pregnant nor breast feeding
This is an open label single agent phase I/II study of pomalidomide in patients with KS. In the phase I portion, up to six subjects will initially be treated with pomalidomide 5mg daily for 21 days of a 28 day cycle. Subject to toxicity evaluation, this dosage may be deescalated to 3mg daily for 21 days of a 28 day cycle in a second cohort of up to six subjects. If either dose proves tolerable, the study will proceed to the phase II portion, and additional subjects to a goal of 15 HIV positive and 10 HIV negative subjects evaluable for response will be added at the highest tolerable dose to gain preliminary information on activity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495598
|Contact: Anaida Widell||(301) firstname.lastname@example.org|
|Contact: Robert Yarchoan, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Robert Yarchoan, M.D.||National Cancer Institute (NCI)|