Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

NCT03601806 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: AMC-100NCI-2017-00390UM1CA121947
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 3

Brief Summary

This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.

Conditions

Human Immunodeficiency Virus 1 Positive; Skin Kaposi Sarcoma

Outcome Measures

Primary Outcomes (3)

• Overall Response Rate

  The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.

  Up to 48 weeks

• Complete Response Rate

  The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate

  Up to 48 weeks

• Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0

  Incidence of Grade 3 or higher toxicity will be reported using percentage and corresponding 95% confidence interval. The binomial proportion and its 95% exact confidence interval will be used to estimate the proportion of participants who experience a grade 3 or higher toxicity.

  Up to 1 year

Secondary Outcomes (2)

• Changes in CD4 T Cell Count

  Baseline to up to 1 year

• Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction

  Baseline to up to 1 year

Other Outcomes (1)

• Changes in Serum Cytokine Levels as Measured by Luminex Assay

  Baseline to up to 48 weeks

Study Arms (1)

Treatment (pomalidomide)

EXPERIMENTAL

Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Drug: Pomalidomide

Interventions

Pomalidomide DRUG

Given PO

Also known as: 4-Amino thalidomide, Actimid, CC-4047, Imnovid, Pomalyst

Treatment (pomalidomide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (pomalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have measurable cutaneous KS that has been pathologically confirmed by an acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC)-approved pathologist; diagnostic tissue must be available to satisfy the tissue submission requirements for central pathology review
• Participants may not show evidence for ongoing improvement in KS lesions in the 4 weeks prior to enrollment
• HIV positive. Documentation of HIV-1 infection by means of any one of the following:
• HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody antigen combination assay;
• 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 multispot 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. 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 E/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 RNA viral load.
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky performance status \[KPS\] \>= 50)
• Life expectancy \>= 12 weeks
• Hemoglobin \>= 8 g/dL
• Absolute neutrophil count (ANC): \>= 1,000 cells/mm\^3 (1.0 x 10\^9/L)
• Platelets: \>= 75,000 cells/mm\^3 (75.0 x 10\^9/L)
• Total bilirubin: =\< 1.5 times the upper limit of normal (ULN), unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be =\< 2 times the ULN
• Serum aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) / alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x ULN
• Estimated or measured creatinine clearance \> 60 mL/minute (1.00 mL/s) (serum creatinine =\< 2.0 mg/dL / 176.8 umol/L)
• Currently receiving local standard of care antiretroviral therapy (ART) for \>= 12 weeks, with HIV viral load =\< 400 copies/mL; participants are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed
• A female of childbearing potential (FCBP) is a female who has achieved menarche at some point and who meets one of the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), or 3) does not have a serum or plasma follicle stimulating hormone (FSH) \> 40 mIU/mL and a history of amenorrhea x \>= 1 year

You may not qualify if:

• Participants who are receiving any other investigational agents
• Any prior use of thalidomide, lenalidomide, or pomalidomide
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide
• Visceral disease requiring cytotoxic chemotherapy (i.e., pulmonary KS, symptomatic gastrointestinal KS). KS-related lymphedema is permitted.
• Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited; in order to be eligible, participants taking zidovudine must change to a different regimen at least 7 days prior to therapy initiation; changes to antiretroviral therapy (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 CYP1A2, which include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine, and ticlopidine is prohibited
• Use of erythropoietin is prohibited
• Co-administration of corticosteroids greater than doses required for treatment of adrenal insufficiency is prohibited
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection for which the participant has not completed at least 14 days of therapy prior to study enrollment and/or is not clinically stable; 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; breastfeeding should be discontinued if the mother is treated with pomalidomide
• Specific KS therapy, including cytotoxic chemotherapy but not including ART, within the past 4 weeks
• Use of other anticancer treatments or agents within the past 4 weeks
• History of malignant tumors other than KS, unless:
• In complete remission for \>= 1 year, or
• Completely resected basal cell carcinoma, or

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator
• University of Arkansas: collaborator
• Montefiore Medical Center: collaborator
• University of Stellenbosch: collaborator
• University of California, Los Angeles: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (3)

Moi University School of Medicine

Eldoret, Kenya

Location

UNC Project Malawi

Lilongwe, Malawi

Location

Uganda Cancer Institute

Kampala, Uganda

Location

MeSH Terms

Interventions

pomalidomide

Results Point of Contact

• Title: Dr. Deukwoo Kwon
• Organization: Consortium for Advancing Management and Prevention of Cancer in People with HIV

deukwoo.kwon@mountsinai.org

501 526-6724

Study Officials

• Susan E. Krown, MD

  AIDS Malignancy Consortium

  STUDY CHAIR

• Samantha Vogt, MD, MPH

  Johns Hopkins University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 26, 2018
• Study Start: April 26, 2021
• Primary Completion: November 29, 2024
• Study Completion: April 10, 2025
• Last Updated: April 13, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-04

Locations

KE (1); MA (1); UG (1)