Ongoing Clinical Trials Actively Recruiting Patients With Kidney Cancer

The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with kidney cancer. The list includes a pilot study and observational, randomized, and nonrandomized phase II and phase III studies evaluating new therapies, combination therapies, surgical techniques, and contrast-enhanced ultrasound diagnostics. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

KIDNEY CANCER

Study Type: Interventional/single-group assignment

Study Title: A Prospective Pilot Study Evaluating Renal Lesions Through Contrast-Enhanced Utrasound in Patients With Renal Cancer and in Those With a Risk Factor for Renal Malignancy

Study Sponsor and Collaborators: University of North Carolina Lineberger Comprehensive Cancer Center

Purpose: This pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations: patients with known renal tumors (cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (cohort 2).

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility of using contrast-enhanced ultrasound in diagnosing renal malignancy in patients with known renal disease and in patients with a risk factor for renal malignancy diagnosed with suspicious or indeterminate lesions (time frame: 12 months)

Principal Investigator: Kimryn Rathmell, MD, University of North Carolina Lineberger Comprehensive Cancer Center. Contact: Gayle Grigson, RN; 919-966-4432; gayle_grigson@med.unc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01751529

Study Title: A Phase II Multi-Center Study of Bevacizumab in Combination With Ixabepilone in Subjects With Advanced Renal Cell Carcinoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To determine whether the combination of ixabepilone, a member of the class of drugs called epothilones, and bevacizumab (Avastin) is effective in treating kidney cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Response rate per RECIST

Principal Investigator: Antonio T. Fojo, MD, National Cancer Institute; 301-496-2831; fojot@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00923130

Study Title: A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma

Study Sponsor and Collaborators: MD Anderson Cancer Center

Purpose: To learn if the surgical removal of the primary tumor or the parts of the cancer that has spread to other parts of the body is a good method for treating patients with kidney cancer. Only the parts of the cancer that has spread will be removed during the surgery.

Ages Eligible for Study: N/A

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: 24-week progression-free/relapse-free survival time (time frame: every 3 months for the first year; 4 months during the second year; every 6 months in the third through fifth year)

Principal Investigator: Eric Jonasch, MD, The University of Texas MD Anderson Cancer Center; 713-792-2830

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00918775

Study Title: A Randomized Phase 2 Study of AMG 386 With or Without Continued Anti-Vascular Endothelial Growth Factor Therapy in Patients With Renal Cell Carcinoma Who Have Progressed on Bevacizumab, Pazopanib, Sorafenib, or Sunitinib

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate how well trebananib (AMG 386) with or without bevacizumab, pazopanib hydrochloride, sorafenib tosylate, or sunitinib malate works in treating patients with kidney cancer that has spread to other places in the body

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Overall tumor response rate defined as the total number of efficacy-evaluable patients who achieve a complete or partial response by Response Evaluation Criteria in Solid Tumors version 1.1 criteria (time frame: up to 8 weeks)

Principal Investigator: Thomas J. Semrad, MD, University of California at David Cancer Center; 916-734-3771; thomas.semrad@ucdmc.ucdavis.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01664182

Study Title: A Prospective Pilot Study Evaluating Renal Lesions Through Contrast-enhanced Utrasound in Patients With Renal Cancer and in Those With a Risk Factor for Renal Malignancy

Study Sponsor and Collaborators: University of North Carolina Lineberger Comprehensive Cancer Center

Purpose: This pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations: patients with known renal tumors (cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (cohort 2).

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility of using contrast-enhanced ultrasound in diagnosing renal malignancy in patients with known renal disease and in patients with a risk factor for renal malignancy diagnosed with suspicious or indeterminate lesions (time frame: 12 months)

Principal Investigator: Kimryn Rathmell, MD, University of North Carolina Lineberger Comprehensive Cancer Center. Contact: Gayle Grigson, RN; 919-966-4432; gayle_grigson@med.unc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01751529

Study Title: A Phase II Study of Bevacizumab Alone or in Combination With TRC105 for Advanced Renal Cell Cancer

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To evaluate how well bevacizumab with or without monoclonal antibody therapy works in treating patients with metastatic kidney cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival (time frame: the duration of time from start of treatment to time of progression or death, assessed at 12 weeks)

Principal Investigator: Tanya B. Dorff, MD, University of South Carolina Norris Comprehensive Cancer Center; 323-865-3900; dorff@usc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01727089

Study Title: Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread to nearby areas of the body

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival (time frame: up to 5 years)

Principal Investigator: Toni K. Choueiri, MD, Alliance for Clinical Trials in Oncology; toni_choueiri@dfci.harvard.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01835158

Study Title: A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

Study Sponsor and Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute

Purpose: To investigate giving sunitinib malate together with or without gemcitabine hydrochloride to determine how effective they are in treating patients with advanced kidney cancer that cannot be removed by ­surgery

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Response rate

Principal Investigator: Naomi S. Balzer-Haas, MD, Abramson Cancer Center of the University of Pennsylvania. Contact: Clinical Trials Office of the Abramson Cancer Center of the University of Pennsylvania at 800-474-9892

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01164228

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Mayo Clinic

Purpose: To study how well pazopanib hydrochloride works in treating patients with metastatic kidney ­cancer

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Overall survival time (time frame: 12 months)

Principal Investigator: Brian A. Costell, MD, Mayo Clinic. Contact: Mayo Clinic Clinical Trials Referral Office: 507-538-7623

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01767636

Study Title: Phase II Trial of Moderate Dose Bolus Interleukin-1 in Metastatic Kidney Cancer

Study Sponsor and Collaborators: Western Regional Medical Center

Purpose: To determine whether interleukin-2 at the dose and schedule used in this study helps increase tumor shrinkage

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival of patients with metastatic kidney cancer who have had disease progression on at least one prior therapy or who have not been treated (time frame: 9 weeks)

Principal Investigator: Walter Quan, MD, Western Regional Medical Center. Contact: Marci Pierog, RN, 623-207-3000; marci.pierog@ctca-hope.com

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01702909 ■