Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
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ClinicalTrials.gov Identifier: NCT02659930 |
Recruitment Status :
Recruiting
First Posted : January 21, 2016
Last Update Posted : January 25, 2023
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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
...
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kaposi Sarcoma | Drug: liposomal doxorubicin Drug: pomalidomide | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 99 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Trial of Pomalidomide in Combination With Liposomal Doxorubicin in Patients With Advanced or Refractory Kaposi Sarcoma |
Actual Study Start Date : | January 13, 2016 |
Estimated Primary Completion Date : | November 30, 2025 |
Estimated Study Completion Date : | November 30, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: 1/Group I
Pomalidomide and liposomal doxorubicin given at escalating doses to patients with KS requiring systemic therapy
|
Drug: liposomal doxorubicin
liposomal doxorubicin IV day 1 of a 28-day cycle Drug: pomalidomide pomalidomide once a day, days 1-21 of a 28-day cycle, at the dose levels described in dose escalation plan |
Experimental: 2/Group I; Antitumor Assessment Phase
Pomalidomide and liposomal doxorubicin, given at the highest tolerated dose to patients with KS requiring systemic therapy
|
Drug: liposomal doxorubicin
liposomal doxorubicin IV day 1 of a 28-day cycle Drug: pomalidomide pomalidomide once a day, days 1-21 of a 28-day cycle, at the dose levels described in dose escalation plan |
Experimental: 3/Group II
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
|
Drug: liposomal doxorubicin
liposomal doxorubicin IV day 1 of a 28-day cycle Drug: pomalidomide pomalidomide once a day, days 1-21 of a 28-day cycle, at the dose levels described in dose escalation plan |
Experimental: 4/Group II; Antitumor Assessment Phase
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
|
Drug: liposomal doxorubicin
liposomal doxorubicin IV day 1 of a 28-day cycle Drug: pomalidomide pomalidomide once a day, days 1-21 of a 28-day cycle, at the dose levels described in dose escalation plan |
- safety/tolerability of dose combinations [ Time Frame: 3 months ]Incidence of dose limiting toxicity and emerging adverse events
- pharmacokinetics of combination therapy [ Time Frame: first 3 days of cycle ]Pomalidomide plasma concentrations
- Quality of life [ Time Frame: 3 months ]assess changes in quality of life in subjects receiving pomalidomide in combination with liposomal doxorubicin
- pulmonary function [ Time Frame: baseline, cycle 2 and at the end of study ]To assess the effect of the combination on pulmonary function, as measured by pulmonary function tests (PFTs) in patients with pulmonary KS
- PET [ Time Frame: 3 months ]evaluate the characteristics of 18fluoro-thymidine (FLT) positron emission tomography (PET) in patients with KS and concurrent KSHV-associated MCD or KICS

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
- Patients must have histologically confirmed Kaposi sarcoma (KS) confirmed by the Laboratory of Pathology, NCI.
- All patients should have either five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion; or other assessable disease
-
Group I: KS requiring systemic therapy (no prior therapy required) and:
- Group I patients should have one or more of the following:
- T1 KS, KS on skin sufficiently widespread that it is not amenable to local therapy, or KS affecting quality of life due to local symptoms or psychological distress
- KS patients with an inadequate response to pomalidomide (either progressive disease or stable disease requiring additional therapy after 4 months)
-
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)
- Group I will exclude patients eligible for Group II (below). Patients with a history of multicentric Castleman disease (MCD) in the absence of any active disease (as assessed by the PI) are eligible for Group I.
- A wash out period off treatment of 3 weeks will be required, except in the case of patients with progressive, severe disease in which delay of treatment cannot be justified (i.e. symptomatic pulmonary KS)
-
Group II: KS (no prior therapy required):
- Concurrent active KSHV-associated multicentric Castleman disease (MCD)
- Active KSHV Inflammatory Cytokine Syndrome (KICS), including those also meeting clinical criteria for KS immune reconstitution syndrome (KS IRIS)
- At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion; or other assessable disease
-
ECOG Performance Status (PS):
- Group I: less than or equal to 2
- Group II: less than or equal to 3
- ECOG PS of 4 will be allowed in Group II only if symptoms due to pulmonary KS. (with Karnofsky = 20%).
- Measurable disease by the criteria proposed by the AIDS Clinical Trials Group Oncology Committee (for KS).
- Patients can be HIV positive or negative.
-
HAART for HIV+ patients:
- All HIV+ patients must be willing to be compliant with HAART
- Group I-on HAART for 1 month with stable disease; however, no minimum time restriction for patients with progressive and/or end-organ threatening disease
- Group II-no minimum time restriction on prior HAART, patients may be HAART naive.
-
Age greater than or equal to 18 years.
--Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with liposomal doxorubicin in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
-
Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count greater than or equal to 1,000/mcL
- Platelets >75,000/mcL
-
Hemoglobin
- Group I: greater than or equal to 8 gm/dL;
- Group II: if anemia attributed to KS, KSHV-MCD, or KICS greater than or equal to 7gm/dL, otherwise greater than or equal to 8 gm/dL
- Total bilirubin less than or equal to1.5 upper limit of normal unless the patient is receiving a protease inhibitor known to be associated with increased bilirubin (e.g. atazanavir), in which case total bilirubin less than or equal to 7.5 mg/dL with direct fraction less than or equal to 0.7
- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR Creatinine clearance >60 mL/min/1.73 m(2) as estimated by either Cockroft-Gault or 24-hour urine collection for patients with creatinine levels above institutional normal
- Cardiac ejection fraction greater than or equal to 50% by echocardiogram
-
Patients with a cumulative lifetime history of anthracycline greater than 430 mg/m(2) are eligible, after consultation with a cardiologist, if there are none of the following cardiac risk factors:
- Diabetes mellitus
- History of acute coronary syndrome
- Hypertension; defined as a sustained systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg OR use of an antihypertensive medication for the indication of hypertension.
- 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
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMSTM program
- Able to take aspirin 81mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5mg/kg once daily)
- Because pomalidomide is an agent with the potential for teratogenic or abortifacient effects, females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to and again within 24 hours before starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
- Patients who are receiving any other investigational agents.
- Patients with primary effusion lymphoma or other concurrent malignancy, except for basal cell carcinoma or squamous carcinoma of the skin or in situ cervical or anal dysplasia
-
History of malignant tumors other than KS or KSHV-MCD, unless:
- In complete remission for greater than or equal to 1 year for the time complete remission was first documented
- Resected basal cell or squamous cell carcinoma of the skin
- In situ cervical or anal dysplasia
- 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
- History of allergic reactions attributed to thalidomide, lenalidomide, or other compounds of similar chemical or biologic composition to pomalidomide or other agents used in study
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding should be discontinued if the mother is treated with pomalidomide. These potential risks may also
apply to other agents used in this study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659930
Contact: Anaida Widell | (240) 760-6074 | anaida.widell@nih.gov | |
Contact: Ramya M Ramaswami, M.D. | (240) 506-1088 | ramya.ramaswami@nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937 |
Principal Investigator: | Ramya M Ramaswami, M.D. | National Cancer Institute (NCI) |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT02659930 |
Other Study ID Numbers: |
160047 16-C-0047 |
First Posted: | January 21, 2016 Key Record Dates |
Last Update Posted: | January 25, 2023 |
Last Verified: | January 23, 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active. |
Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@ Genomic data are made available via dbGaP through requests to the data custodians |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HIV AIDS Multicentric Castleman Disease |
Sarcoma, Kaposi Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Virus Diseases Infections Neoplasms, Vascular Tissue Doxorubicin Liposomal doxorubicin Pomalidomide |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |