45 Participants Needed

Pomalidomide for Kaposi Sarcoma

Recruiting at 15 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Must be taking: Antiretroviral therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but certain medications are prohibited, such as those containing zidovudine and strong inhibitors of specific enzymes. It's important to discuss your current medications with the trial team to ensure there are no interactions.

What data supports the effectiveness of the drug pomalidomide for treating Kaposi Sarcoma?

In a study, pomalidomide was shown to be effective in treating Kaposi Sarcoma, with 73% of patients responding to the treatment. It was well tolerated and improved patients' quality of life, regardless of their HIV status.12345

Is pomalidomide safe for humans?

Pomalidomide, used for treating Kaposi Sarcoma, is generally considered safe in humans, but like any medication, it can have side effects. It is an oral drug that modifies the immune system and has been approved by the FDA for its anti-angiogenic activity (reducing blood vessel growth in tumors).678910

What makes the drug pomalidomide unique for treating Kaposi Sarcoma?

Pomalidomide is unique for treating Kaposi Sarcoma because it is an oral drug that modulates the immune system, making it suitable for patients with or without HIV. It offers a new option for those with advanced disease who have already tried other treatments, and it can be administered in resource-limited settings.12111213

Research Team

SL

Samantha L Vogt

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

Adults with confirmed Kaposi Sarcoma (KS) and measurable disease, who understand the trial and consent to participate. They must have proper organ function, a life expectancy over 6 months, stable HIV treatment if positive, and agree to REMS program for drug safety. Pregnant women, those with certain heart conditions or mental illnesses that affect compliance, prior use of similar drugs like thalidomide or active infections are excluded.

Inclusion Criteria

My bilirubin levels are within the normal range, or slightly higher if I'm on certain medications.
Participants must agree to participate in and comply with the mandatory POMALYST Risk Evaluation and Mitigation Strategy (REMS) program
Your AST and ALT levels in your blood should be below 2.5 times the normal limit.
See 18 more

Exclusion Criteria

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.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive pomalidomide orally once daily on days 1-21, repeated every 28 days for up to 12 cycles

12 months
Monthly visits (in-person)

Extended Treatment

Participants with complete or partial response continue pomalidomide for an additional 12 cycles

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Every 6 months (in-person)

Treatment Details

Interventions

  • Pomalidomide
Trial OverviewThe trial is testing pomalidomide's effectiveness on KS patients. Pomalidomide aims to halt blood vessel growth in tumors, boost the immune system response against cancer cells and may directly kill them. The study involves CT scans, X-rays, biopsies and biospecimen collection to assess this effect.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (pomalidomide)Experimental Treatment5 Interventions
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with CR or PR continue pomalidomide for an additional 12 cycles with the option to continue thereafter in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with stable disease may continue pomalidomide for an additional 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray imaging throughout the trial. Patients may undergo CT as clinically indicated. Patients also undergo blood sample collection and may optionally undergo tissue biopsy during screening and on the trial.

Pomalidomide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Pomalyst for:
  • Multiple myeloma
  • Kaposi's sarcoma
🇪🇺
Approved in European Union as Imnovid for:
  • Multiple myeloma
  • Kaposi's sarcoma
🇨🇦
Approved in Canada as Pomalyst for:
  • Multiple myeloma
  • Kaposi's sarcoma
🇯🇵
Approved in Japan as Imnovid for:
  • Multiple myeloma

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

Pomalidomide, an oral immune modulatory agent, was found to be well tolerated and effective in treating Kaposi's sarcoma (KS) in a study of 22 patients, with a response rate of 73%, including 60% in HIV-infected patients and 100% in HIV-uninfected patients.
The treatment led to rapid responses, with a median time to response of 4 weeks, and improved health-related quality of life, indicating its potential as a viable therapy for KS, especially in resource-limited settings.
Pomalidomide for Symptomatic Kaposi's Sarcoma in People With and Without HIV Infection: A Phase I/II Study.Polizzotto, MN., Uldrick, TS., Wyvill, KM., et al.[2022]
A 72-year-old male developed serious lung injury, characterized by dyspnea and ground glass opacities, two months after starting treatment with pomalidomide for multiple myeloma, highlighting a potential adverse effect of this drug.
Discontinuing pomalidomide led to a rapid recovery of symptoms and CT-scan abnormalities, suggesting that recognizing and addressing pomalidomide-induced lung injury is crucial for patient safety, especially as its use increases.
Pomalidomide-induced lung injury: A case report.Vivien, A., Ancel, J., Godet, S., et al.[2023]
Pomalidomide, an immunomodulatory agent derived from thalidomide, has shown significant anti-cancer effects in patients with relapsed and refractory multiple myeloma, particularly in those resistant to other treatments like lenalidomide and bortezomib.
Combination therapy with pomalidomide and low-dose dexamethasone has demonstrated improved response rates and survival outcomes compared to higher doses of dexamethasone or pomalidomide alone, leading to further investigations into its use with various other anti-myeloma agents.
Pomalidomide.Engelhardt, M., Wäsch, R., Reinhardt, H., et al.[2015]

References

Pomalidomide for Symptomatic Kaposi's Sarcoma in People With and Without HIV Infection: A Phase I/II Study. [2022]
Pomalidomide-induced lung injury: A case report. [2023]
Pomalidomide. [2015]
Pomalidomide. [2019]
A phase I, dose-escalation study of pomalidomide (CC-4047) in combination with gemcitabine in metastatic pancreas cancer. [2022]
Lenalidomide and the Expanding Toolkit to Manage Kaposi Sarcoma. [2022]
Immunophenotypic analysis in participants with Kaposi sarcoma following pomalidomide administration. [2023]
Phase II Trial of Lenalidomide in HIV-Infected Patients with Previously Treated Kaposi's Sarcoma: Results of the ANRS 154 Lenakap Trial. [2021]
Safety, Activity, and Long-term Outcomes of Pomalidomide in the Treatment of Kaposi Sarcoma among Individuals with or without HIV Infection. [2022]
Therapeutic Perspectives in the Systemic Treatment of Kaposi's Sarcoma. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Pharmacokinetics and bioequivalence of two pomalidomide capsules in healthy chinese subjects under fasting and fed conditions. [2023]
Pomalidomide: first global approval. [2022]
Pomalidomide: A Review in Relapsed and Refractory Multiple Myeloma. [2018]