Ixazomib + Chemotherapy for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Pavlos Msaouel | MD Anderson Cancer Center

Overseen byPavlos Msaouel

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well ixazomib, gemcitabine, and doxorubicin work in treating patients with kidney cancer that has spread to other places in the body (locally advanced or metastatic). Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ixazomib, gemcitabine, and doxorubicin may work better in treating patients with kidney cancer.

Eligibility Criteria

This trial is for patients with advanced or metastatic kidney cancer, including rare types like RMC and rhabdoid tumors. Eligible participants may have had prior treatments but must show disease progression. They need to be over 12 years old, in fairly good health (ECOG 0-2), and meet specific blood count and organ function criteria. Those with controlled brain metastases can join if they meet certain conditions.

Inclusion Criteria

Your heart pumps blood at a healthy rate, at least 45%.

It doesn't matter if my kidney tumor has been removed or is still there.

I am 12 or older and have both my agreement and my parents' consent.

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Exclusion Criteria

I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

Severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study

Known allergy to any of the study medications, their analogues, or excipients

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Participant Groups

The study tests a combination of ixazomib (which blocks enzymes needed for cell growth) with chemotherapy drugs gemcitabine and doxorubicin on patients with locally advanced or metastatic kidney cancer. The goal is to see if this mix works better than current treatments at stopping tumor growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib, gemcitabine, doxorubicin)Experimental Treatment6 Interventions

INDUCTION: Patients receive ixazomib PO, gemcitabine IV over 90 minutes, and doxorubicin IV over 15-30 minutes on day 1. Treatment repeats every 14 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ixazomib PO and gemcitabine IV over 90 minutes. Cycles repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Adriamycin for: