Pomalidomide Treatment in Patients With Kaposi Sarcoma
A Multicenter Phase II Study of Pomalidomide Monotherapy in Kaposi Sarcoma
3 other identifiers
interventional
45
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2022
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 13, 2026
April 1, 2026
4.5 years
October 6, 2020
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of response
The Kaplan-Meier (K-M) method will be used to describe duration of response for all treated participants. The cumulative proportion of study participants still in response at one year will be estimated using the point estimate and the 95% confidence interval using Greenwood's formula for the standard error of the K-M estimate. The proportional hazards model will be used to evaluate the association of human immunodeficiency virus (HIV) status and pretreatment status on duration of response.
From the first date at which a partial or complete response is documented until progression or death due to any cause, assessed up to 5 years
Secondary Outcomes (4)
Overall response rate (ORR)
Up to 5 years post treatment
Incidence of adverse events
Up to 5 years post treatment
Changes in visceral disease
Baseline up to 5 years post treatment
Response duration in participants treated with pomalidomide
From the first date of which a partial or complete response is documented until first date of progression, assessed up to 5 years
Other Outcomes (5)
Effect of treatment on changes in tumor microenvironment
Baseline up to 5 years post treatment
Effect of pomalidomide on CD4 lymphocyte counts
Up to within 7 days of treatment discontinuation
Effect of pomalidomide on HIV viral load
Up to within 7 days of treatment discontinuation
- +2 more other outcomes
Study Arms (1)
Treatment (pomalidomide)
EXPERIMENTALPatients 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.
Interventions
Undergo x-ray imaging
Undergo tissue biopsy
Undergo blood sample collection
Undergo CT
Given PO
Eligibility Criteria
You may qualify if:
- Participant is able to understand and willing to sign a written informed consent document
- Participants must have histologically or cytologically confirmed cutaneous KS. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be \>= 700 mm\^2
- Participants must have documentation of HIV status
- If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step).
- If HIV positive, documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider
- Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multi-spot antibody differentiation assay
- Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States \[U.S.\] Food and Drug Administration \[FDA\])
- WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme (E)/carbon immunoassay (CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) viral load
- Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of pomalidomide in participants \< 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Life expectancy of greater than 6 months
- Hemoglobin \>= 8 g/dL (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
- Absolute neutrophil count (ANC): \>= 1,000/mm\^3 (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
- +16 more criteria
You may not qualify if:
- Participant who is receiving any other investigational agents
- Participant has symptomatic visceral KS involving the lungs or gastrointestinal (GI) tract that requires immediate chemotherapy or radiotherapy. Participants with minimally symptomatic visceral disease not requiring immediate tumor shrinkage are eligible if in provider judgment potential disease progression will not cause a hazard for the participant
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide
- Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited. Changes to ART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Use of medications or substances that are strong inhibitors of cytochrome P450 (CYP)1A2, which include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine, and ticlopidine is prohibited. Co-administration of efavirenz, an inhibitor of CYP1A2, with strong inhibitors of CYP3A4 and P-glycoprotein (P-gp) is prohibited. Use of erythropoietin is prohibited. Co-administration of corticosteroids greater than doses required for treatment of adrenal insufficiency is prohibited. Because the lists of these agents are constantly changing, it is important to regularly consult frequently updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the informed consent/enrollment procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection for which the participants have not completed at least 14 days of therapy prior to study enrollment into OPEN Step-1 (Treatment Assignment - Registration Step) and/or is not clinically stable
- Participant has symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
- Pregnant women are excluded from this study because pomalidomide is a thalidomide analog with the potential for teratogenic or abortifacient effects. 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
- Participants who have had chemotherapy, radiotherapy, or therapies to target KS lesions within 4 weeks (6 weeks for nitrosoureas or mitomycin C) with the exception of ART, before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
- Participants with high clinical suspicion of concurrent Castleman disease or IL6 related inflammatory disease
- For a reference of signs and symptoms consistent with IL6 related inflammatory disease or KSHV inflammatory cytokine syndrome (KICS) can refer to publication from Polizzotto Minnesota (MN), et al. Clinical Features and Outcomes of Patients with Symptomatic Kaposi Sarcoma Herpesvirus (KSHV)-associated Inflammation: Prospective Characterization of KICS. Clinical Infectious Diseases, 2016. 62(6):730-8
- Participants with a history of malignant tumors other than KS, unless:
- In complete remission for \>= 1 year, or
- Completely resected basal cell or squamous skin carcinoma, or
- In situ squamous cell carcinoma (SCC) of the cervix or anus
- Participants with grade \>= 3 peripheral neuropathy
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
University of Illinois
Chicago, Illinois, 60612, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mount Sinai Hospital
New York, New York, 10029, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Street at Quentin Mease Health Center
Houston, Texas, 77004, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samantha L Vogt
AIDS Malignancy Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 8, 2020
Study Start
March 18, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.