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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)

Must not have

Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

pharmacokinetics of combination therapy

safety/tolerability of dose combinations

Secondary study objectives

PET

Quality of life

pulmonary function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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