Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (NCT01038778) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer
United States47 participantsStarted 2009-10-29
Plain-language summary
This phase I/II trial studies the side effects and best dose of entinostat when given together with aldesleukin and to see how well this works in treating patients with kidney cancer that has spread to other places in the body. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Aldesleukin may stimulate the white blood cells to kill kidney cancer cells. Giving entinostat together with aldesleukin may be a better treatment for metastatic kidney cancer.
Who can participate
Age range
18 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 must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable; the histology must be clear cell carcinoma or predominant clear cell carcinoma
* Patients may have received up to two prior therapies including vascular endothelial growth factor (VEGF), mammalian target of rapamycin (mTOR) and programmed cell death (PD)-1/PD ligand 1 (L1) inhibitors; prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
* Patients must have measurable or evaluable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0
* Life expectancy of greater than 6 months
* Hemoglobin \>= 12 g/dL
* Leukocytes \>= 3,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelets \>= 100,000/mm\^3
* Total bilirubin =\< 1.5 x laboratory upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x laboratory upper limit of normal
* Creatinine =\< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of \>= 50 ml/min
* Lactate dehydrogenase (LDH) within normal limits (WNL)
* Corrected calcium =\< 10 mg/dL
* Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5
* Urine protein \< 1+; if \>= 1+, 24 hour urine protein should be obtained and should be …
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
Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I
Timeframe: 84 days
2
Overall Response Rate (Complete Plus Partial) (Phase II)