October 2014 VOL 5, NO 5

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Clinical Trials Tracker

New Clinical Trials Under Way

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_ rowe@med.unc.edu. 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 clinical@agensys.com. 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 ikaplan@caregroup.harvard.edu, or Nordine Benhaga, MD, at 617-667-4679 or nbenhaga@bidmc.harvard.edu. 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’s immune system. Biologic markers of autophagy in tumor and normal tissues, such as peripheral blood mononuclear cells and renal parenchyma, will be measured. Biologic markers will also be measured 1 month after surgery.

Patients who are aged ?19 years with stage I to IV primary or metastatic RCC with a planned nephrectomy are eligible to participate in the study if additional criteria are met. This study is expected to enroll 20 patients and will be conducted at the University of Pittsburgh Medical Center, PA. For more information, contact Jodi K. Maranchie, MD, at 412-605-3019 or maranchiejk@upmc.edu, or Kimberly Jones, RN, BSN, at 412-623-2764. The NLM Identifier is NCT01144169.

Panobinostat and Everolimus in Patients with Metastatic or Unresectable RCC
The purpose of this phase 1/2, open-label, interventional study is to determine optimal dosing and potential side effects of panobinostat administered together with everolimus in patients with metastatic or unresectable RCC who did not respond to previous treatment with sunitinib malate or sorafenib tosylate. Patients in the first treatment arm will receive panobinostat orally once daily on days 1, 3, 4, 8, 10, and 12, and oral everolimus once daily on days 1 to 21. Treatment repeats every 21 days in the absence of disease progression or severe toxicity. This study is expected to enroll 48 patients.

To be eligible for participation, patients should be aged ?18 years with a histologically confirmed diagnosis of metastatic or unresectable RCC, predominant clear cell component, and metastatic disease that has progressed within 6 months of stopping treatment; additional inclusion and exclusion criteria must be met. This study will be conducted in New York at the Roswell Park Cancer Institute in Buffalo and the University of Rochester Medical Center. For more information, contact Roberto Pili, Principal Investigator, at 877-275-7724 or roberto.pili@roswellpark.org. The NLM Identifier is NCT01582009.

Dose Escalation of TRC105 in Combination with Axitinib in Patients with Advanced RCC
The goal of this phase 1, open-label study is to determine the optimal phase 2 dose for TRC105 when administered in combination with standard-dose axitinib in patients with advanced RCC. The study also assesses the safety and tolerability of TRC105 as part of this combination therapy. The primary outcome measure of this study is to determine the maximum tolerated dose of TRC105 in combination with axitinib during a 1-year time frame. The secondary outcome is to assess plasma TRC105 concentration at specific time points.

It is estimated that 18 patients will be enrolled in this study. Patients who are aged ?18 years with histologic evidence of advanced RCC whose disease has progressed following treatment with at least 1 previous therapy (sunitinib, pazopanib, sorafenib, tivozanib), and who have no history of other carcinomas within the past 5 years are eligible to participate in the study if additional criteria are met. Study locations include Alabama, California, and Massachusetts. For more information, contact Manoj Jivani at mjivani@traconpharma.com, or Bonne Adams at badams@traconpharma.com. The NLM Identifier is NCT01806064.

ASONEP in the Treatment of Refractory RCC
The objective of this phase 2, multicenter, open-label, single-arm study is to assess the efficacy, safety, and tolerability of ASONEP (sonepcizumab/LT1009) monotherapy in the treatment of patients with refractory RCC. It is estimated that the study will recruit 39 patients, and the treatment arm will consist of ASONEP 15 mg/kg administered by intravenous infusion over 90 minutes once a week every 4 consecutive weeks of patients’ treatment cycle. The primary outcome measure is progression-free survival evaluated at 8 weeks. The study will utilize a 2-cohort design; enrollment of cohort 2 will proceed depending on the rate of progression-free survival in cohort 1. Secondary outcome measures include safety and tolerability, measured as the incidence and frequency of adverse events.

To be eligible for the study, patients must be aged ?18 years with unresectable and locally advanced recurrent or metastatic RCC, have histological evidence of clear cell RCC, demonstrate disease measurable by Response Evaluation Criteria in Solid Tumors, and meet other inclusion and exclusion criteria. Study locations include California, South Carolina, and Tennessee. For more information, contact France LaPierre-Holme, Study Director, at 858-678-0800. The NLM Identifier is NCT01762033.

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