New Clinical Trials Under Way

October 2014 Vol 5, No 5

Categories:

Clinical Trials

The following clinical trials are currently recruiting patients with renal cell carcinoma (RCC) for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Neoadjuvant Pazopanib in RCC
The purpose of this phase 2 study is to evaluate the effect of neoadjuvant pazopanib on disease response and recurrence and to establish predictive biomarkers of drug activity in patients with histologically confirmed, localized RCC. The study will examine complete response and partial response associated with pazopanib at 8 weeks, and is expected to enroll 56 patients. Patients aged ?18 years with nonmetastatic, clinical stage II RCC and no evidence of extranodal involvement are eligible to participate if other criteria are met.

The primary outcome for this study is response rate after 8 weeks of neoadjuvant treatment with pazopanib. Secondary outcome measures include recurrence-free survival, number of adverse events, and the impact of pazopanib on surgical approach. Study locations include New York, North Carolina, and Texas. For more information, contact Gayle Grigson, RN, at 919-966-4432 or gayle_grigson@med. unc.edu, or Donna Rowe, RN, at 919-966-7359 or donna_ This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01361113.

Pazopanib Versus Temsirolimus in Poor-Risk Clear Cell RCC
This randomized, phase 2, open-label study compares pazopanib with temsirolimus in the treatment of patients with clear cell RCC. Pazopanib inhibits the growth of blood vessels that supply nutrients necessary for tumor growth, while temsirolimus blocks the growth of cancer cells. The study will assess the efficacy and safety of each drug, and is expected to enroll 90 patients. Participants will be allocated to receive 800 mg of pazopanib orally once daily or 25 mg of temsirolimus by infusion for 30 to 60 minutes weekly. Evaluations will occur at baseline, prior to treatment, and every 8 weeks.

Patients who are aged ?18 years with pathologic evidence of metastatic or locally advanced RCC with a clear cell component and disease state measurable by Response Evaluation Criteria in Solid Tumors are eligible to participate in the study if other criteria are met. The primary outcome is progression-free survival (PFS), measured every 8 weeks from baseline to disease progression. PFS is defined as the time from initiation of the study drug to time of first disease progression. Radiologic studies using computed tomography or magnetic resonance imaging will be performed every 8 weeks to evaluate response. This study will be conducted at the University of Texas MD Anderson Cancer Center in Houston. For more information, contact Nizar M. Tannir, MD, Principal Investigator, at 713-792-2830. The NLM Identifier is NCT01392183.

Safety, Pharmacokinetics, and Effectiveness of AGS-16C3F Monotherapy in RCC
In this phase 1, open-label, multicenter study, investigators are evaluating the safety, pharmacokinetics, and effectiveness of AGS-16C3F monotherapy in patients with RCC of clear cell or papillary histology. This study aims to establish a safe dose of AGS-16C3F by intravenous infusion and to assess safety and efficacy in 2 expanded cohorts. The first cohort will include patients with clear cell histology, and the second cohort will include patients with papillary histology. The study expects to recruit 72 patients. To be eligible for study participation, patients should be aged ?18 years, have a histologically confirmed diagnosis of metastatic RCC, have measurable disease according to Response Evaluation Criteria in Solid Tumors, and meet additional criteria.

The primary outcome measure of the study is incidence of adverse events within a 24-month time frame. Secondary outcomes include incidence of antibody formation and the measurement of tumor response. The study will be conducted in New York, Washington, and Michigan. For more information about the trial, contact Agensys Clinical Research and Development at 424-280-5000 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01672775.

Cyberknife Radiosurgery in RCC
The purpose of this phase 2, open-label study is to evaluate the role of radiosurgery in patients with clinically localized primary RCC. This study is expected to enroll 46 patients. Participants will receive radiation doses based on the size of the tumor. Treatment will take 3 to 4 days, but no more than 14 days overall. To be eligible for this study, patients must be aged ?18 years, have histologic evidence of stage I RCC with a tumor size of ?8 cm, have at least 1 gold fiducial placed in or around the tumor, and meet additional inclusion and exclusion criteria.

The primary outcome of this study is to determine freedom from local tumor progression at 6 months in patients treated with CyberKnife radiosurgery. Secondary outcome measures include the impact of therapy on quality of life and an evaluation of adverse events. This study is being conducted at Beth Israel Deaconess Medical Center in Boston. For more information, contact Irving D. Kaplan, MD, at 617-667-2345 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Nordine Benhaga, MD, at 617-667-4679 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01890590.

Hydroxychloroquine Before Surgery in Patients with Primary RCC
The purpose of this phase 1 study is to determine whether the use of hydroxychloroquine before nephrectomy in patients with primary RCC will facilitate the elimination of cancer cells; another goal is to examine the degree to which the study drug affects the patient

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Oncology clinical trials have greatly advanced treatment options for patients with cancer, resulting in remarkable improvements in survival and well-being.

Last modified: November 5, 2020

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