Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic K… (NCT03587662) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
United States30 participantsStarted 2018-08-17
Plain-language summary
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry. Also eligible are patients with other rare SMARCB1-negative tumors of the kidney, such as advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare RMC variant occurring in individuals without sickle hemoglobinopathies), and adult-onset malignant rhabdoid tumors. The principal investigator (PI) is the final arbiter in questions related to eligibility.
* Patients will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ. Patients with prior nephrectomy can be screened for enrollment at any time following the procedure.
* Patients must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures \>= 15 mm with conventional techniques or \>= 10 mm with more sensitive techniques such as magnetic resonance imaging (MRI) or spiral computed tomography (CT) scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Patients with disease confined to bone may be eligible if a measurable lytic defect is present or a serum marker is elevated (\> 4 x upper limit of normal \[ULN\]). The PI is the final arbiter in questions related to measurability.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response (complete response or partial response) assessed by Response Evaluation Criteria in Solid (RECIST) 1.1
Timeframe: Up to 2 years
2
Disease control (stable disease or better) measured by RECIST 1.1