Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03601806|
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus 1 Positive Skin Kaposi Sarcoma||Other: Laboratory Biomarker Analysis Drug: Pomalidomide||Phase 2|
I. To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated Kaposi sarcoma (KS) in sub-Saharan Africa and is safe and tolerable.
I. To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population.
I. To assess the effect of pomalidomide treatment on serum cytokine levels. II. To evaluate if changes in serum cytokine levels correlate with clinical response.
Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 48 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals With Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Treatment (pomalidomide)
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
- Overall response rate [ Time Frame: Up to 48 weeks ]The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.
- Complete response rate [ Time Frame: Up to 48 weeks ]The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate
- 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 [ Time Frame: Up to 30 days after the last dose of study treatment ]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.
- Changes in CD4 T cell count [ Time Frame: Baseline to up to 30 days after last dose of study drug ]Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated using generalized estimating equations.
- Changes in HIV viral load as measured by HIV quantitative polymerase chain reaction [ Time Frame: Baseline to up to 30 days after last dose of study drug ]Changes in CD4 counts and HIV viral load will be evaluated using generalized estimating equations.
- Changes in serum cytokine levels as measured by Luminex assay [ Time Frame: Baseline to up to 48 weeks ]General estimating equations will be used to evaluate changes in cytokine levels over time. Logistic regression analyses will be used to evaluate the association between cytokine levels and clinical response.
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): NCT03601806
|Moi University School of Medicine|
|Contact: Naftali Busakhala 254-722-496-933 firstname.lastname@example.org|
|Principal Investigator: Naftali Busakhala, MBChB MMed|
|Bugando Medical Centre|
|Contact: Nestory Masalu 255-783-0-00004 email@example.com|
|Principal Investigator: Nestory Masalu, MD MMed|
|Uganda Cancer Institute|
|Contact: Abrahams Omoding 256-772-555-865 firstname.lastname@example.org|
|Principal Investigator: Abrahams Omoding, MBChB MMED|
|University of Zimbabwe Clinical Research Centre / Parirenyatwa Hospital|
|Contact: Margaret Borok-Williams 263-4-791631 ext 2272 email@example.com|
|Principal Investigator: Margaret Borok-Williams, MBChB|
|Study Chair:||Susan E. Krown, MD||AIDS Malignancy Consortium|
|Study Chair:||Samantha Vogt, MD, MPH||Johns Hopkins University|