The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy as treatment for renal cell carcinoma. These studies are researching combination chemotherapies; immunotherapies; radiosurgery techniques; stereotactic body radiation therapy; contrast screening for recurrence; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Phase I/II
Study Title: Phase I/II Trial of Vandetanib in Combination With Metformin in Subjects With Hereditary Leiomyomatosis and Renal Cell Carcinoma or Succinate Dehydrogenase–Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
Study Type: Phase I/II/interventional/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute, National Institutes of Health Clinical Center
Purpose: To test the combination of metformin and vandetanib in people with advanced kidney cancer. Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose in people with certain kidney cancers.
Primary Outcome Measures: Phase 1 component: To establish the safety and maximum tolerated dose of vandetanib and metformin when used in combination in patients with metastatic renal cell carcinoma [time frame: 1–2 years]. Phase 2 component: To determine the overall response rate (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) following treatment with the combination of vandetanib and metformin in patients with (1) advanced renal cell carcinoma associated with hereditary leiomyomatosis or succinate dehydrogenase–associated kidney cancer and (2) advanced sporadic/non–hereditary leiomyomatosis and papillary renal cell carcinoma [time frame: 2–3 years]
Principal Investigator: Ramaprasad Srinivasan, MD, National Cancer Institute; contact Martha Ninos, RN, (301) 496-6353, mninos@mail.nih.gov
ClinicalTrials.gov Identifier: NCT02495103
Study Title: Phase I/II Study of Ixazomib With Pegylated Interferon-alpha 2b in Metastatic Renal Cell Carcinoma
Study Type: Phase I/II/interventional/single-group sssignment
Study Sponsor and Collaborators: Fox Chase Cancer Center
Purpose: To test the combination of pegylated interferon-alpha 2b with ixazomib in metastatic renal cell carcinoma. Researchers believe that by disabling the protein complex nuclear factor kB (NF-kB), which controls the transfer of genetic information, and using ixazomib, they can promote necrotic cell death of renal cell carcinoma using interferon alpha-2b.
Primary Outcome Measures: Nonhematologic toxicity ≥ grade 3 per Common Terminology Criteria for Adverse Events (CTCAE) v4 except: [time frame: up to week 8]
Principal Investigator: Daniel Geynisman, MD, Fox Chase Cancer Center; (215) 728-4300, daniel.geynisman@fccc.edu
ClinicalTrials.gov Identifier: NCT02447887
Phase II
Study Title: A Phase II Study of CyberKnife Radiosurgery for Renal Cell Carcinoma
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Beth Israel Deaconess Medical Center
Purpose: CyberKnife-based radiosurgery is a way to deliver large doses of radiation accurately to a tumor. The purpose of this protocol is to evaluate the role of radiosurgery for the treatment of clinically localized primary renal cell carcinoma.
Primary Outcome Measures: To determine the freedom from local tumor progression in patients treated with CyberKnife radiosurgery for primary renal tumors at 6 months [time frame: 2 years]
Principal Investigator: Irving D. Kaplan, MD, Beth Israel Deaconess Medical Center; (617) 667-2345, ikaplan@caregroup.harvard.edu
ClinicalTrials.gov Identifier: NCT01890590
Study Title: A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Radiofrequency Ablation for the Treatment of Localized Renal Cell Carcinoma
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: University of Michigan Cancer Center
Purpose: To assess whether stereotactic body radiation therapy can provide comparable local control, with similar or improved toxicity rates compared with radiofrequency ablation when treating small renal cell carcinomas.
Primary Outcome Measures: Proportion of patients with local control of disease [time frame: 12 months]; cumulative incidence of grade 2 and greater toxicities [time frame: up to 30 days after the last study treatment]
Principal Investigator: Daniel Spratt, MD, University of Michigan Cancer Center; (734) 936-4300, sprattda@umich.edu
ClinicalTrials.gov Identifier: NCT02138578
Study Title: Two- and Three-Dimensional Contrast-Enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Thomas Jefferson University
Purpose: To determine whether contrast-enhanced ultrasound can be used to assess the recurrence of renal cell carcinoma after cryoablation compared with contrast-enhanced computed tomography or magnetic resonance (the standard evaluation)
Primary Outcome Measures: Identification of renal cell carcinoma recurrence [time frame: day of study]
Principal Investigator: John R. Eisenbrey, PhD, Thomas Jefferson University; (215) 503-5188, john.eisenbrey@jefferson.edu
ClinicalTrials.gov Identifier: NCT02440334
Study Title: A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features
Study Type: Phase II/interventional
Study Sponsor and Collaborators: Eastern Cooperative Oncology Group, National Cancer Institute
Purpose: To study the combination of sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced unresectable kidney cancer
Primary Outcome Measures: Response rate
Principal Investigator: Naomi S. Balzer-Haas, MD, Abramson Cancer Center of the University of Pennsylvania; reference clinicaltrials.gov for all 99 study locations and contact information
ClinicalTrials.gov Identifier: NCT01164228 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
