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Anti-tumor antibiotic
Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma
Phase 1
Waitlist Available
Led By Ramya M Ramaswami, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
KS patients with an inadequate response to liposomal doxorubicin, paclitaxel, or other systemic chemotherapy (either progressive disease or stable disease requiring additional therapy after 6 cycles)
KS patients with an inadequate response to pomalidomide (either progressive disease or stable disease requiring additional therapy after 4 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing a combination of two drugs, pomalidomide and liposomal doxorubicin, to treat Kaposi sarcoma in people with HIV.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, heart issues due to Doxil (especially in patients with previous anthracycline use), blood clots despite preventive medication, fatigue from multiple drugs, and potential risks associated with aspirin or heparin used for thromboprophylaxis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Kaposi's sarcoma didn't respond well to chemotherapy.
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My Kaposi's sarcoma didn't improve with pomalidomide treatment.
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My Kaposi sarcoma diagnosis has been confirmed by a pathology lab.
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I have KICS, possibly with KS IRIS.
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I can take aspirin daily or a substitute if I'm allergic.
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My organ and bone marrow functions are normal.
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I am 18 years old or older.
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I have KSHV-associated multicentric Castleman disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
pharmacokinetics of combination therapy
safety/tolerability of dose combinations
Secondary outcome measures
PET
Quality of life
pulmonary function
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
liposomal doxorubicin
2009
Completed Phase 3
~600
pomalidomide
2011
Completed Phase 3
~1060
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,097 Total Patients Enrolled
Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
347 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking any other experimental drugs.You have had allergic reactions to certain medications similar to the one being studied.My Kaposi's sarcoma didn't respond well to chemotherapy.My Kaposi's sarcoma didn't improve with pomalidomide treatment.I have a type of cancer that is not skin cancer, cervical, or anal dysplasia.I am not breastfeeding because I am being treated with pomalidomide.I have KICS, possibly with KS IRIS.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My Kaposi sarcoma diagnosis has been confirmed by a pathology lab.I have at least five skin lesions from Kaposi's sarcoma that haven't been treated with radiation or surgery.I can take aspirin daily or a substitute if I'm allergic.I've had anthracycline doses over 430 mg/m2 but no heart risks after seeing a cardiologist.My Kaposi's sarcoma is widespread, affects my quality of life, or causes distress.My organ and bone marrow functions are normal.Patients can be either HIV positive or negative.I am 18 years old or older.I have KSHV-associated multicentric Castleman disease.I agree to follow the pregnancy testing schedule as required.I have been cancer-free for over a year from any cancer other than KS or KSHV-MCD.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Group I
- Group 2: 4/Group II; Antitumor Assessment Phase
- Group 3: 2/Group I; Antitumor Assessment Phase
- Group 4: 3/Group II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there further opportunities to enroll in this clinical experiment?
"Clinicaltrials.gov confirms that recruitment of participants into this trial is ongoing, having first commenced on 13th January 2016 and was last modified on 31st October 2022."
Answered by AI
Has the Food and Drug Administration sanctioned liposomal doxorubicin?
"Despite some evidence of efficacy, our team at Power assessed liposomal doxorubicin to have a low level of safety with a score of 1 on the scale. This is because it's only in its initial testing phase."
Answered by AI
Is this clinical trial unprecedented in its scope?
"Since 1997, Alfacell has sponsored research on liposomal doxorubicin that was awarded Phase 3 drug approval after a trial involving 300 patients. Presently, 446 trials are underway in 68 different countries and 2110 cities."
Answered by AI
What is the current enrollment size for this medical experiment?
"Affirmative. The trial, which was first posted on January 13th 2016 and recently amended on October 31st 2022, is currently recruiting from 2 sites for a total of 99 patients. This information can be found using clinicaltrials.gov as a reference point."
Answered by AI
What diseases has liposomal doxorubicin been efficacious in treating?
"Liposomal doxorubicin is an accepted therapy for lymphoma, hodgkins and other ailments such as carcinoma, bronchogenic, neuroblastoma (nb), and Sezary syndrome."
Answered by AI
Have there been recent investigations regarding liposomal doxorubicin?
"At present, 446 clinical studies concerning liposomal doxorubicin are being conducted with 129 of those trials in their final stage. Most research sites for this drug are found within New york City; however, 26392 other locations have been utilised to undertake investigations into liposomal doxorubicin."
Answered by AI
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