Pomalidomide Treatment in Patients With Kaposi Sarcoma (NCT04577755) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pomalidomide Treatment in Patients With Kaposi Sarcoma
United States45 participantsStarted 2022-03-18
Plain-language summary
This phase II trial studies the effect of pomalidomide in treating patients with Kaposi sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is able to understand and willing to sign a written informed consent document
* Participants must have histologically or cytologically confirmed cutaneous KS. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be \>= 700 mm\^2
* Participants must have documentation of HIV status
* If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step).
* If HIV positive, documentation of HIV-1 infection by means of any one of the following:
* Documentation of HIV diagnosis in the medical record by a licensed health care provider
* Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name
* Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multi-spot antibody di…
What they're measuring
1
Duration of response
Timeframe: From the first date at which a partial or complete response is documented until progression or death due to any cause, assessed up to 5 years