Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (NCT01038778)
Phase I/II Study of High Dose Interleukin 2, Aldesleukin, in Combination With the Histone Deacetylase Inhibitor Entinostat in Patients With Metastatic Renal Cell Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (14 items).
Location: USC / Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who have received more than two prior therapies
- Concurrent use of valproic acid is not allowed
- Patients may not be receiving any other investigational agents
- Patients with untreated central nervous system (CNS) metastases; patients should have a head CT/magnetic resonance imaging (MRI) within 28 days prior to treatment initiation; patients with previously excised/gamma knifed solitary or oligometastases and controlled disease are eligible
- Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (\< the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months, hypertension (defined as blood pressure of \> 160 mmHg systolic and/or \> 90 mmHg diastolic on medication) history of peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with a history of allergy to entinostat or other medications that have a benzamide structure (i.e. tiapride, remoxipride, and clebopride)
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with entinostat
- Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with entinostat. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- Serious or non-healing wound, ulcer or bone fracture
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 therapy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- Roswell Park Cancer Institute — Buffalo, New York
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clear Cell Renal Cell Carcinoma
- Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery — Fairbanks, Alaska
- Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma — Phoenix, Arizona
- A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors — Birmingham, Alabama
- Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors — Duarte, California
- Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma — Oklahoma City, Oklahoma
Explore by condition: All Clear Cell Renal Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.