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Proteasome Inhibitor
Ixazomib for Kaposi Sarcoma
Phase 2
Recruiting
Led By Ronald T Mitsuyasu
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks post treatment
Awards & highlights
Study Summary
This trial looks at how well ixazomib works to treat patients with Kaposi sarcoma by blocking enzymes needed for cell growth.
Who is the study for?
Adults with Kaposi sarcoma, good performance status (able to carry out daily activities), and adequate organ function can join. They must have measurable skin lesions, not be pregnant or breastfeeding, use contraception if of childbearing potential, and have a life expectancy over 3 months. HIV-positive patients need stable antiretroviral therapy for at least 4 weeks.Check my eligibility
What is being tested?
The trial is testing Ixazomib's effectiveness on Kaposi sarcoma by seeing if it can stop tumor growth. It involves taking the drug orally and monitoring its impact through health questionnaires and assessments.See study design
What are the potential side effects?
Ixazomib may cause side effects like fatigue, digestive issues, rash or other skin reactions, blood disorders such as low platelet counts or anemia, nerve damage leading to pain or numbness in limbs (peripheral neuropathy), and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most of my daily activities but might need help.
Select...
I have at least five visible skin lesions or one large lesion covering 700 mm^2.
Select...
My skin cancer has been confirmed as Kaposi sarcoma through a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Change in CD4 counts
Change in Kaposi-sarcoma associated herpes virus (KSHV) viral load (VL)
Change in human immunodeficiency virus (HIV) VL
+2 moreOther outcome measures
Change in quality of life
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib)Experimental Treatment3 Interventions
Patients receive ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response may continue treatment for an additional 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib Citrate
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,585 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,400 Total Patients Enrolled
Ronald T MitsuyasuPrincipal InvestigatorAIDS Malignancy Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most of my daily activities but might need help.I haven't taken proteasome inhibitors for Kaposi sarcoma in the last 2 years, nor have I ever taken ixazomib.I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.My platelet count is at least 75,000 without recent transfusions.My kidney function, measured by creatinine levels, is normal or my creatinine clearance is at least 30 mL/min.I am not taking any strong medication that affects liver enzymes or St. John's wort.If you have HIV, your Kaposi's sarcoma should not have recently improved from taking only antiretroviral therapy (ART), as this could make it difficult to evaluate the response to the study treatment.I am HIV positive and have been on effective HIV treatment for at least 12 weeks.I am not pregnant or breastfeeding.I agree to use effective birth control during and 90 days after the study.I have been screened for hepatitis B and know my status.I am HIV positive and have been on a stable HIV treatment for at least 4 weeks without plans to change it.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I still have active Kaposi's sarcoma lesions after recent treatment and it's been over 4 weeks since my last therapy.You have had allergic reactions to drugs similar to ixazomib.I don't have another cancer that could affect this treatment's safety or results.I have recovered from side effects of previous cancer treatments, except for hair loss.I have severe nerve pain in my hands or feet.You must have a certain level of a type of white blood cell called neutrophils in your blood.You need to have proof of your HIV status. If you are HIV negative, you need to have a negative HIV rapid test within 21 days before joining the trial. If you are HIV positive, you need to have proof of HIV-1 infection.You are expected to live for more than 3 months.Your hemoglobin level should be more than 8 grams per deciliter within 21 days before joining the study.I have hepatitis C without cirrhosis and my liver function tests meet the study's criteria.I have at least five visible skin lesions or one large lesion covering 700 mm^2.My heart function is classified as class 2B or better, assessed within the last 6 months.I do not have any serious ongoing illnesses or infections that are not under control.I have not had major surgery in the last 14 days.Your bilirubin level is not more than 1.5 times the upper limit of normal.My skin cancer has been confirmed as Kaposi sarcoma through a biopsy.I have Kaposi sarcoma that is causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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