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Pomalidomide for Kaposi Sarcoma
Study Summary
This trial is testing how well pomalidomide works in treating KS. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT02011113Trial Design
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Who is running the clinical trial?
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- My bilirubin levels are within the normal range, or slightly higher if I'm on certain medications.Your AST and ALT levels in your blood should be below 2.5 times the normal limit.I can take daily low-dose aspirin.I am HIV positive, on stable ART for 12 weeks or more, and have an undetectable viral load.I haven't had chemotherapy, radiotherapy, or specific treatments for KS lesions in the last 4 to 6 weeks, except for ART.You have a known condition that makes your blood clot more easily.I have previously used pomalidomide, lenalidomide, or thalidomide.I do not have any ongoing serious illnesses or infections.I need urgent treatment for my Kaposi's sarcoma affecting my lungs or GI tract.My kidney function, measured by creatinine or clearance, is within the required range.I have had blood clots in my veins or arteries before.I have had cancer other than Kaposi's sarcoma.I am not taking any medication that contains zidovudine.Your white blood cell count is at least 1000 per cubic millimeter.I have taken two pregnancy tests before starting pomalidomide, both negative.My legal representative can sign the consent for me if I'm unable to make decisions.I may have Castleman disease or a related inflammatory condition.If you don't have HIV, you need to have a recent negative HIV test.If you have HIV, you need to show proof that you are infected with HIV-1.My Kaposi's sarcoma has been confirmed by tissue examination.You have had allergic reactions to drugs similar to pomalidomide.My cancer has less than 5 measurable spots, but their total size is at least 700 mm^2.I have at least five visible skin lesions that can be measured.I do not have severe heart issues, unstable chest pain, irregular heartbeats, or mental health/social situations that would prevent me from following the study's requirements.I have severe nerve damage in my hands or feet.I am fully active and can carry on all pre-disease activities without restriction.You are expected to live for at least 6 more months.Your hemoglobin level is equal to or higher than 8 grams per deciliter within 7 days before joining the study.Your platelet count is at least 75,000 per cubic millimeter within the week before joining the study.I am 18 years old or older.
- Group 1: Treatment (pomalidomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities for individuals to participate in this research endeavor?
"The evidence from clinicaltrials.gov verifies that this medical trial is still enrolling participants as of October 4th 2022, having been first posted on March 30th 2022."
How many participants have signed up for the clinical trial so far?
"Absolutely, the information on clinicaltrials.gov confirms that recruitment is ongoing for this medical trial. The initial post date was March 30th 2022 and it has recently been refreshed with new data as of October 4th 2022. 45 patients need to be enrolled across 4 locations."
Has the United States Food and Drug Administration (FDA) granted approval for Pomalidomide?
"We at Power assessed Pomalidomide's safety to be a 2, as the drug is currently undergoing Phase 2 testing with data supporting its relative security but yet no definitive proof of efficacy."
Could you shed light on any prior investigations involving Pomalidomide?
"Presently, 87 Pomalidomide trials are underway with 10 of them in their final phase. The majority of the research is taking place in Dallas, Texas but there are 2,785 other sites that have been established for this medication's clinical testing."
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