Trial of Ixazomib for Kaposi Sarcoma

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    41
  • sponsor
    AIDS Malignancy Consortium
Updated on 8 April 2021

Summary

This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Description

PRIMARY OBJECTIVE:

I. Determine the overall response rate of ixazomib in participants with Kaposi sarcoma.

SECONDARY OBJECTIVES:

I. Determine safety and tolerability of ixazomib. II. Assess changes in Kaposi-sarcoma associated herpesvirus (KSHV) viral load (VL) by ixazomib.

III. Correlate changes in KSHV VL with tumor response. IV. For human immunodeficiency virus (HIV)-positive participants, assess changes in CD4 counts and HIV viral load.

EXPLORATORY OBJECTIVE:

I. Assess changes in quality of life during ixazomib therapy.

OUTLINE

Patients receive ixazomib orally (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.

After completion of study treatment, patients are followed up for 4 weeks, then periodically for up to 2 years.

Details
Condition Skin, Kaposi's Sarcoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, kaposi sarcoma
Treatment questionnaire administration, quality-of-life assessment, Ixazomib Citrate
Clinical Study IdentifierNCT04305691
SponsorAIDS Malignancy Consortium
Last Modified on8 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Participants with grade 1 peripheral neuropathy with pain on clinical examination during the screening period
Major surgery within 14 days before enrollment
Participants with symptomatic visceral Kaposi sarcoma
Participants who have had prior treatment that included a proteasome inhibitor

Exclusion Criteria

Participants who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or other agents used in study
Chronic systemic treatment using strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort is not allowed. Patients who are on chronic use of strong CYP3A inducers must come off 14 days before receiving ixazomib treatment. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent 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; uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; or psychiatric illness/social situations that would limit compliance with study requirements. This includes infections requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment but excludes ongoing antibiotic therapy for opportunistic infection (OI) prophylaxis
Participants with a second prior or concurrent malignancy that has a natural history or treatment regimen that has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Pregnant women are excluded from this study because ixazomib is expected to cause fetal harm if used during pregnancy. It is not known if ixazomib is excreted into breast milk, but due to the potential for serious adverse events in a nursing infant, breastfeeding must be discontinued during therapy and for 90 days after the last ixazomib dose
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before entering the study
Participants who have not recovered from other adverse events due to prior anti-cancer therapy (i.e., have residual toxicity > grade 1), excluding alopecia
Participants who are seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). All participants will be required to be screened for hepatitis B. Participants with resolved infection (i.e. participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and/or antibodies to hepatitis B surface antigen (anti-HBs) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV deoxyribonucleic acid (DNA) levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of hepatitis B virus (HBV) vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
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