62 Participants Needed

Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma

Recruiting at 1 trial location
AW
RM
Overseen ByRamya M Ramaswami, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
Must be taking: Antiretrovirals, Aspirin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Background: Kaposi sarcoma (KS) is a cancer most often seen in people with HIV. It causes lesions. These are usually on the skin but sometimes in the lymph nodes, lungs, and gastrointestinal tract. Researchers think a combination of drugs may help treat KS. Objective: To test a combination of the anti-cancer drugs pomalidomide (CC-4047) and liposomal doxorubicin (Doxil) in people with KS. Eligibility: People ages 18 and over with KS Design: Participants will be screened with: Medical history Questionnaires Physical exam Blood, urine, and heart tests Chest X-ray Biopsy: A small sample of tissue is taken from a KS lesion. Possible CT scan Possible exam of lungs or gastrointestinal tract with an endoscope: A flexible instrument examines inside the organ. Participants will take the drugs in 4-week cycles. They will take Doxil through an IV on Day 1 of each cycle. They will take CC-4047 tablets by mouth each day for the first 3 weeks of each cycle. Participants will have many visits: Before starting treatment To start each cycle Day 15 of first 2 cycles Visits include repeats of screening tests and: Multiple blood draws Photographs of lesions Participants will keep a drug diary. Participants will take aspirin or other drugs to prevent blood clots. Participants with HIV will have combination antiretroviral therapy. Some participants will have a PET scan. Participants will continue treatment as long as they tolerate it and their KS improves. After treatment, they will have several follow-up visits for up to 5 years ...

Will I have to stop taking my current medications?

The trial requires a 3-week period without treatment (washout period) for most participants, except those with severe, progressive disease. This suggests you may need to stop some current medications, but it's best to discuss your specific situation with the trial team.

What data supports the effectiveness of the drug Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma?

Research shows that liposomal doxorubicin (Doxil) is effective in treating Kaposi's sarcoma, especially in patients with HIV, by reducing tumor size and improving symptoms. It is also associated with fewer side effects compared to traditional chemotherapy, making it a safer option for patients.12345

Is the combination of Pomalidomide and Liposomal Doxorubicin safe for humans?

Liposomal Doxorubicin (also known as Doxil or Caelyx) is generally considered safer than conventional doxorubicin, with reduced heart-related side effects and less hair loss. However, it can still cause side effects like myelosuppression (a decrease in bone marrow activity), digestive symptoms, and skin issues such as hand-foot syndrome. Pomalidomide's safety profile is not detailed here, but it is important to discuss potential risks with your healthcare provider.12567

How is the drug Pomalidomide + Liposomal Doxorubicin unique for treating Kaposi Sarcoma?

This drug combination is unique because it uses pegylated liposomal doxorubicin, which is designed to reduce severe side effects like heart damage and low blood cell counts while maintaining high drug concentration in tumor tissues, potentially leading to better outcomes compared to conventional chemotherapy.12389

Research Team

RM

Ramya M Ramaswami, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults with Kaposi sarcoma (KS), including those with HIV. Participants must have confirmed KS, measurable lesions or assessable disease, and normal organ/marrow function. They should not have had certain treatments that would affect lesion assessment and must be willing to follow specific safety programs like POMALYST REMS if taking pomalidomide.

Inclusion Criteria

All HIV+ patients must be willing to be compliant with HAART
My Kaposi's sarcoma didn't respond well to chemotherapy.
All study participants must agree to be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program
See 13 more

Exclusion Criteria

You are taking any other experimental drugs.
You have had allergic reactions to certain medications similar to the one being studied.
I have a type of cancer that is not skin cancer, cervical, or anal dysplasia.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive pomalidomide and liposomal doxorubicin in 4-week cycles, with Doxil administered via IV on Day 1 and pomalidomide tablets taken daily for the first 3 weeks of each cycle.

Ongoing until optimal tumor response or unacceptable toxicity
Visits before starting treatment, to start each cycle, and on Day 15 of the first 2 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits for up to 5 years.

Up to 5 years
Several follow-up visits

Treatment Details

Interventions

  • Liposomal Doxorubicin
  • Pomalidomide
Trial OverviewThe study tests a drug combo for treating KS: IV liposomal doxorubicin on day one of each cycle and daily oral pomalidomide tablets for the first three weeks of each cycle. Treatment continues as long as it's tolerated and effective, with regular monitoring up to five years post-treatment.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: 4/Group II; Antitumor Assessment PhaseExperimental Treatment2 Interventions
Pomalidomide and liposomal doxorubicin, given at the highest tolerated dose to patients with KS or KS with concurrent KSHV-associated MCD or KICS requiring systemic therapy
Group II: 3/Group IIExperimental Treatment2 Interventions
Pomalidomide with liposomal doxorubicin given at escalating doses in to patients with advanced KS or KS and concurrent KSHV-associated MCD or KICS requiring systemic therapy
Group III: 2/Group I; Antitumor Assessment PhaseExperimental Treatment2 Interventions
Pomalidomide and liposomal doxorubicin, given at the highest tolerated dose to patients with KS requiring systemic therapy
Group IV: 1/Group IExperimental Treatment2 Interventions
Pomalidomide and liposomal doxorubicin given at escalating doses to patients with KS requiring systemic therapy

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

🇪🇺
Approved in European Union as Caelyx for:
  • Ovarian cancer
  • Breast cancer
  • Kaposi's sarcoma
  • Multiple myeloma
🇺🇸
Approved in United States as Doxil for:
  • Ovarian cancer
  • Breast cancer
  • Kaposi's sarcoma
  • Multiple myeloma
🇨🇦
Approved in Canada as Caelyx for:
  • Ovarian cancer
  • Breast cancer
  • Kaposi's sarcoma
🇯🇵
Approved in Japan as Caelyx for:
  • Ovarian cancer

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

Pegylated liposomal doxorubicin (PLD) and daunorubicin citrate liposome (DNX) show higher response rates and less toxicity compared to conventional chemotherapy regimens for advanced Kaposi's sarcoma, making them more effective treatment options.
Patients treated with PLD or DNX experienced improved health-related quality of life in several areas, despite some common side effects like myelosuppression and stomatitis.
Use of liposomal anthracyclines in Kaposi's sarcoma.Krown, SE., Northfelt, DW., Osoba, D., et al.[2019]
Liposomal doxorubicin was effective in treating Kaposi's sarcoma in HIV-infected patients, with five out of eight participants achieving a complete clinical response and three showing a partial response after six months of treatment.
While the treatment led to significant improvements, all patients experienced relapse after stopping therapy, highlighting the need for ongoing treatment; however, neutropenia was managed successfully with filgrastim, allowing for uninterrupted therapy.
Treatment of Kaposi's sarcoma with liposomal doxorubicin.Bergin, C., O'Leary, A., McCreary, C., et al.[2019]
In a Phase I/II study involving 15 patients with HIV-related cutaneous Kaposi's sarcoma, Doxil (liposomal doxorubicin) demonstrated a high partial response rate of 73%, indicating its efficacy as a palliative treatment for this severe condition.
Doxil was well tolerated among patients, with manageable toxicity primarily affecting blood cell counts, suggesting it is a safer option for patients with poor prognosis who have previously undergone chemotherapy.
Liposomal doxorubicin (Doxil): an effective new treatment for Kaposi's sarcoma in AIDS.James, ND., Coker, RJ., Tomlinson, D., et al.[2019]

References

[Doxil--pegylated liposomal doxorubicin]. [2018]
Use of liposomal anthracyclines in Kaposi's sarcoma. [2019]
Treatment of Kaposi's sarcoma with liposomal doxorubicin. [2019]
Liposomal doxorubicin (Doxil): an effective new treatment for Kaposi's sarcoma in AIDS. [2019]
Caelyx/Doxil for the treatment of metastatic ovarian and breast cancer. [2022]
Pegylated liposomal doxorubicin: a guide to its use in various malignancies. [2018]
Pegylated liposomal doxorubicin (PLD): enhanced skin toxicity in areas of vitiligo. [2022]
Disseminated classic Kaposi's sarcoma. Two cases with excellent response to pegylated liposomal doxorubicin. [2018]
Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma: evidence of symptom palliation from chemotherapy. [2022]