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Anti-tumor antibiotic
Ixazomib + Chemotherapy for Kidney Cancer
Phase 2
Waitlist Available
Led By Pavlos Msaouel
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescent patients age 12 years and older with signed assent and parental consent
Absolute neutrophil count >= 1000/uL without growth factor support
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs to treat kidney cancer. Ixazomib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. 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.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver issues reflected by altered blood tests, heart complications such as reduced heart function, nerve damage presenting as numbness or tingling in extremities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 or older and have both my agreement and my parents' consent.
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My white blood cell count is healthy without needing medication.
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My kidney tumor is rare, advanced, or has spread, and lacks SMARCB1.
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I have at least one tumor that can be measured.
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I am able to get out of my bed or chair and move around.
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My cancer is advanced or has spread, and tests show a specific protein is missing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control (stable disease or better) measured by RECIST 1.1
Objective response (complete response or partial response) assessed by Response Evaluation Criteria in Solid (RECIST) 1.1
Secondary outcome measures
Biomarker analysis of biomarkers PDI, BiP, eIF2aP assessed in tumor tissue samples
Duration of response
IL-6 measured serum samples
+3 moreSide effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637467%
Rash
50%
Diarrhoea
50%
Decreased appetite
33%
Nasopharyngitis
33%
Taste disorder
33%
White blood cell count decreased
17%
Bone pain
17%
Compression fracture
17%
Constipation
17%
Malaise
17%
Tibia fracture
17%
Neutrophil count decreased
17%
Anaemia
17%
Pyrexia
17%
Platelet count decreased
17%
Spinal compression fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Gemcitabine
FDA approved
Ixazomib
FDA approved
Ixazomib
FDA approved
Doxorubicin
FDA approved
Doxorubicin
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,797,984 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,334 Total Patients Enrolled
Pavlos MsaouelPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I am 12 or older and have both my agreement and my parents' consent.My white blood cell count is healthy without needing medication.My liver enzymes are within normal limits, except I have liver metastasis.I have not been diagnosed or treated for another cancer within the last 2 years.I have not had cancer treatment within the restricted time.My cancer has spread to my brain or its coverings and is not under control.You have a positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV).Your total bilirubin level must be less than or equal to 1.5 mg/dl.My kidney tumor is rare, advanced, or has spread, and lacks SMARCB1.I have at least one tumor that can be measured.I have had immunotherapies or targeted therapies before.I am able to get out of my bed or chair and move around.Your blood clotting tests should be within a certain range before joining the study.I am following the required pregnancy prevention measures.I am a male and follow the required birth control guidelines.I have not had major surgery or significant injury recently.My nerve damage does not severely affect my daily activities.I still have side effects from my last chemotherapy.My cancer is advanced or has spread, and tests show a specific protein is missing.I have a stomach or intestine condition that affects how I absorb pills.Your hemoglobin level is 9 grams per deciliter or higher.Your kidneys work well enough to filter out waste from your blood.I haven't taken certain medications in the last 14 days.My brain metastases are under control and meet specific criteria.Your platelet count is at least 75,000 per microliter.Your condition has worsened despite the last treatment you received.
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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