30 Participants Needed

Ixazomib + Chemotherapy for Kidney Cancer

PM
Overseen ByPavlos Msaouel
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received anticancer therapies within 2 weeks before starting the trial, and certain medications like strong CYP3A inducers are not allowed within 14 days before the first dose of ixazomib. It's best to discuss your current medications with the trial team to ensure eligibility.

Is the combination of Ixazomib and Doxorubicin safe for treating kidney cancer?

Doxorubicin, a drug often used in cancer treatment, can cause kidney damage and heart problems. It's important for patients receiving Doxorubicin to have their kidney function monitored regularly.12345

How is the drug Ixazomib + Chemotherapy for Kidney Cancer different from other treatments?

The combination of Ixazomib with Doxorubicin and Gemcitabine for kidney cancer is unique because it includes Ixazomib, a proteasome inhibitor, which is not commonly used in standard kidney cancer treatments. This combination may offer a novel approach by potentially enhancing the effectiveness of chemotherapy through a different mechanism of action.16789

What data supports the effectiveness of the drug combination Ixazomib and Doxorubicin for kidney cancer?

The research does not provide direct evidence supporting the effectiveness of Ixazomib and Doxorubicin for kidney cancer. However, one study showed that doxorubicin, when intensified in combination with other drugs, significantly reduced tumor volume in a specific type of kidney cancer (malignant rhabdoid tumor of the kidney).3691011

Who Is on the Research Team?

Pavlos Msaouel | MD Anderson Cancer Center

Pavlos Msaouel

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.
See 16 more

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
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive ixazomib orally, gemcitabine intravenously over 90 minutes, and doxorubicin intravenously over 15-30 minutes on day 1. Treatment repeats every 14 days for up to 13 cycles.

26 weeks
Every 2 weeks

Maintenance

Patients receive ixazomib orally and gemcitabine intravenously over 90 minutes. Cycles repeat every 14 days for up to 2 years.

104 weeks
Every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion at 30 and 90 days, then every 3 months thereafter.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Doxorubicin
  • Gemcitabine
  • Ixazomib
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib, gemcitabine, doxorubicin)Experimental Treatment6 Interventions

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

🇺🇸
Approved in United States as Adriamycin for:
🇪🇺
Approved in European Union as Doxorubicin for:
🇨🇦
Approved in Canada as Doxorubicin for:
🇯🇵
Approved in Japan as Doxorubicin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a phase II study involving 12 patients with refractory renal cell cancer, pegylated-liposomal doxorubicin (Doxil) was administered with mild toxicities, primarily related to mucositis and hand-foot syndrome.
Despite the treatment being well-tolerated, no objective responses were observed in 11 evaluable patients, indicating that pegylated-liposomal doxorubicin does not demonstrate efficacy in this type of cancer.
Phase II trial of pegylated-liposomal doxorubicin (Doxil) in renal cell cancer.Skubitz, KM.[2019]
Dexrazoxane (DZR) significantly protects against doxorubicin (DOX)-induced kidney damage in rats, improving renal function and survival rates after DOX treatment.
DZR works by reducing oxidative stress, inhibiting apoptosis, and preventing fibrosis in the kidneys, suggesting it could be a valuable co-treatment to mitigate the nephrotoxic effects of DOX.
Dexrazoxane Alleviated Doxorubicin-Induced Nephropathy in Rats.Hu, H., Xie, C., Weng, Z., et al.[2022]
SC-33428, a new drug similar to doxorubicin, showed stronger bone marrow suppression in rats compared to doxorubicin, but had less harmful effects on the heart and kidneys.
The lower concentrations of SC-33428 in the body after administration suggest it may have a better safety profile than doxorubicin while maintaining similar effectiveness against tumors.
Toxicological studies with a novel synthetic anthracycline, the bis-hydrazone bridged analog of 4-demethoxydaunorubicin (SC-33428).Zbinden, G., Beilstein, AK., Bachmann, E.[2013]

Citations

Barleria prionitis L. extracts ameliorate doxorubicin-induced acute kidney injury via modulation of oxidative stress, inflammation, and apoptosis. [2023]
A combination of vinblastine and doxorubicin with interferon alpha. [2019]
Malignant rhabdoid tumor of the kidney: significantly improved response to pre-operative treatment intensified with doxorubicin. [2014]
Phase II trial of pegylated-liposomal doxorubicin (Doxil) in renal cell cancer. [2019]
Phase II study of vinblastine-CCNU, triazinate, and dactinomycin in advanced renal cell cancer. [2015]
Dexrazoxane Alleviated Doxorubicin-Induced Nephropathy in Rats. [2022]
Toxicological studies with a novel synthetic anthracycline, the bis-hydrazone bridged analog of 4-demethoxydaunorubicin (SC-33428). [2013]
Doxorubicin hydrochloride-associated renal failure. [2013]
Paeonol protects against doxorubicin-induced cardiotoxicity by promoting Mfn2-mediated mitochondrial fusion through activating the PKCε-Stat3 pathway. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Advances in the treatment of Wilms' tumor. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Doxorubicin for favorable histology, Stage II-III Wilms tumor: results from the National Wilms Tumor Studies. [2016]
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