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Immunomodulatory Agent
Pomalidomide for Kaposi Sarcoma
Phase 2
Recruiting
Led By Samantha L Vogt
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
Participants must be able to take aspirin 81 mg daily as prophylactic anticoagulation
Participants must have histologically or cytologically confirmed cutaneous KS
Must not have
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
Participants with any prior use of pomalidomide, lenalidomide or thalidomide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well pomalidomide works in treating KS. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells.
Who is the study for?
Adults with confirmed Kaposi Sarcoma (KS) and measurable disease, who understand the trial and consent to participate. They must have proper organ function, a life expectancy over 6 months, stable HIV treatment if positive, and agree to REMS program for drug safety. Pregnant women, those with certain heart conditions or mental illnesses that affect compliance, prior use of similar drugs like thalidomide or active infections are excluded.
What is being tested?
The trial is testing pomalidomide's effectiveness on KS patients. Pomalidomide aims to halt blood vessel growth in tumors, boost the immune system response against cancer cells and may directly kill them. The study involves CT scans, X-rays, biopsies and biospecimen collection to assess this effect.
What are the potential side effects?
Pomalidomide can cause side effects such as blood clots; lowered white blood cell counts increasing infection risk; fatigue; allergic reactions in those sensitive to its components; potential harm to unborn babies hence strict pregnancy prevention measures for women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take daily low-dose aspirin.
Select...
My Kaposi's sarcoma has been confirmed by tissue examination.
Select...
My cancer has less than 5 measurable spots, but their total size is at least 700 mm^2.
Select...
I have at least five visible skin lesions that can be measured.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy, radiotherapy, or specific treatments for KS lesions in the last 4 to 6 weeks, except for ART.
Select...
I have previously used pomalidomide, lenalidomide, or thalidomide.
Select...
I need urgent treatment for my Kaposi's sarcoma affecting my lungs or GI tract.
Select...
I have had blood clots in my veins or arteries before.
Select...
I have had cancer other than Kaposi's sarcoma.
Select...
I am not taking any medication that contains zidovudine.
Select...
I may have Castleman disease or a related inflammatory condition.
Select...
I have severe nerve damage in my hands or feet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of response
Secondary study objectives
Changes in visceral disease
Incidence of adverse events
Overall response rate (ORR)
+1 moreOther study objectives
Change in Kaposi's sarcoma-associated herpesvirus (KSHV) viral copy number
Effect of pomalidomide on CD4 lymphocyte counts
Effect of pomalidomide on HIV viral load
+2 moreSide effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
FATIGUE
11%
EPISTAXIS
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pomalidomide)Experimental Treatment5 Interventions
Patients 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 complete response, partial response, or 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 CT as clinically indicated. Patients also undergo blood sample collection and may optionally undergo tissue biopsy during screening and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2740
Pomalidomide
2011
Completed Phase 2
~1060
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,015 Total Patients Enrolled
Samantha L VogtPrincipal InvestigatorAIDS Malignancy Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin levels are within the normal range, or slightly higher if I'm on certain medications.Your AST and ALT levels in your blood should be below 2.5 times the normal limit.I can take daily low-dose aspirin.I am HIV positive, on stable ART for 12 weeks or more, and have an undetectable viral load.I haven't had chemotherapy, radiotherapy, or specific treatments for KS lesions in the last 4 to 6 weeks, except for ART.You have a known condition that makes your blood clot more easily.I have previously used pomalidomide, lenalidomide, or thalidomide.I do not have any ongoing serious illnesses or infections.I need urgent treatment for my Kaposi's sarcoma affecting my lungs or GI tract.My kidney function, measured by creatinine or clearance, is within the required range.I have had blood clots in my veins or arteries before.I have had cancer other than Kaposi's sarcoma.I am not taking any medication that contains zidovudine.Your white blood cell count is at least 1000 per cubic millimeter.I have taken two pregnancy tests before starting pomalidomide, both negative.My legal representative can sign the consent for me if I'm unable to make decisions.I may have Castleman disease or a related inflammatory condition.If you don't have HIV, you need to have a recent negative HIV test.If you have HIV, you need to show proof that you are infected with HIV-1.My Kaposi's sarcoma has been confirmed by tissue examination.You have had allergic reactions to drugs similar to pomalidomide.My cancer has less than 5 measurable spots, but their total size is at least 700 mm^2.I have at least five visible skin lesions that can be measured.I do not have severe heart issues, unstable chest pain, irregular heartbeats, or mental health/social situations that would prevent me from following the study's requirements.I have severe nerve damage in my hands or feet.I am fully active and can carry on all pre-disease activities without restriction.You are expected to live for at least 6 more months.Your hemoglobin level is equal to or higher than 8 grams per deciliter within 7 days before joining the study.Your platelet count is at least 75,000 per cubic millimeter within the week before joining the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pomalidomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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