Clinical Trials

Cancer Type: Renal/Kidney


2011-159

Title: CA209010: A Randomized, Blinded, Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) in Subjects with Progressive Advanced Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy.

DescriptionThis study is for people with clear-cell renal cell carcinoma (a type of kidney cancer) who have received prior treatment with either bevacizumab, sunitinib, sorafenib, or pazopanib (anti-angiogenic therapy).

The purpose of this study is to test the effectiveness, safety, and tolerability of an investigational drug called BMS-936558 at different dose levels and to determine the most effective dose for further study. An investigational drug, like BMS-936558, is one that is not approved by the Food and Drug Administration (FDA). BMS-936558 is administered as a 60-minute intravenous infusion once every 3 weeks.

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2012-1230

Title: ECOG E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No evidence of Disease Following Metastatectomy.

Description: The purpose of this study is to determine whether taking an oral drug known as pazopanib (Votrient®) will reduce the risk of the cancer recurring in the future. Pazopanib is approved by the FDA for patients who have metastatic renal cell carcinoma. However, it has not been tested in patients who have had all visible areas of their cancer removed surgically, and is considered experimental in this situation. We dont know if pazopanib will be helpful to patients in this scenario. There is currently no standard of care for patients in this situation but careful observation without treatment is considered reasonable.

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Hospitals Offering This Trial: Lombardi/Georgetown University Hospital, Washington Hospital Center

Contact: Divyesh Kukadiya; Holly DiFebo
Email: dk365@georgetown.edu; hmd27@georgetown.edu
Phone: 202-687-7354; 202-687-2007

2012-1088

Title: CA209-025: A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs Everolimus in Subejcts with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy.

Description: The purpose of this study is to compare the clinical benefit provided by BMS-936558 to that of everolimus in subjects with advanced or metastatic renal cell carcinoma who have received prior anti-angiogenic therapy.

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Hospitals Offering This Trial: Lombardi/Georgetown University Hospital

Contact: Holly DiFebo
Email: hmd27@georgetown.edu
Phone: 202-687-2007

2012-1131

Title: A041-04: A Phase 2 Randomized Study of Dalantercept in Combination with Axitinib Compared to Axitinib Alone in Patients with Advanced Renal Cell Carcinoma.

Description: To evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of dalantercept in combination with axitinib as second line treatment in patients with metastatic renal cell carcinoma.

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Hospitals Offering This Trial: Lombardi/Georgetown University Hospital

Contact: Holly DiFebo
Email: hmd27@georgetown.edu
Phone: 202-687-2007

2012-1235

TitleS1107: Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma.

DescriptionThis study is for subjects with a rare type of kidney cancer called papillary kidney cancer that has spread to other parts of the body or cannot be treated with surgery.

Lab research shows that two proteins found in the body called MET and EGFR are important for the growth and spread of papillary kidney cancer. The study drug ARQ 197 blocks the MET protein and erlotinib is a drug that blocks EGFR function. Lab studies suggest that the combination of ARQ 197 and erlotinib may slow down the growth of papillary kidney cancer better than ARQ 197 alone.

The purpose of this study is to find out what effects there are to treating this type of kidney cancer with the study drug ARQ 197 or a combination of ARQ 197 with erlotinib. Subjects on this study will be randomized (like the flip of a coin) to receive either ARQ 197 alone or ARQ 197 and erlotinib. Both of these drugs are pills that are taken by mouth at home.

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2013-0130

Title: SWOG S0931: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study.

Description: The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein called mTOR. Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, you will get either everolimus or placebo (a pill with no medication). You will not get both.

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Hospitals Offering This Trial: Lombardi/Georgetown University Hospital, Washington Hospital Center

Contact: Divyesh Kikadiya;Holly DiFebo
Email: dk365@georgetown.edu; hmd27@goergetown.edu
Phone: 202-687-7354;202-687-2007

2013-0778

Title: A031203: Randomized Phase II Study Comparing Cabozantinib (NSC# 761968 And IND# 116059) With Comercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma.

Description: The purpose of this study is to find out what effects sunitinib and cabozantinib have on advanced or metastatic renal cell cancer.

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  • Protocol
  • HIPAA
  • ICF

Hospitals Offering This Trial: Lombardi/Georgetown University Hospital] [Franklin Square Hospital Center, Washington Hospital Center

Contacts: Divyesh Kukadiya; David Sellers
Email: dk365@georgetow.edu; dms275@georgetown.edu
Phone: 202-687-7354; 202-687-7606

2013-1317

Title: W029074 A Phase II, Randomized Study Of MPDL3280a Administered As Monotherapy Or In Combination With Bevacizumab Versus Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma.

Description: This study is for patients with advanced or metastatic renal cell carcinoma (kidney cancer that is extensive or has spread) who have not been treated with chemotherapy or other anti-cancer medicines.

The purpose of this study is to find out whether an investigational drug called MPDL3280A given alone or with another medicine called bevacizumab, can help patients with kidney cancer live longer without growth of the kidney cancer compared with another standard medicine called sunitinib.

Subjects on this study will be randomly assigned (like the flip of a coin) to one of three treatment groups: MPDL3280A with bevacizumab, MPDL3280A alone, or sunitinib. Subjects who receive MPDL3280A alone or sunitinib may be able to change treatment to MPDL3280A and bevacizumab if their kidney cancer gets worse or grows if they are able to give a new tumor biopsy at that time.

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2013-1163

Title: Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects At High Risk Of Recurrent RCC

Description: The purpose of this research study is to investigate the safety and effectiveness of a study drug, axitinib, after surgery for patients with “high risk” recurrence of kidney cancer. Tumors need blood vessels to grow, and axitinib is thought to work by preventing new blood vessels from growing.The U.S. Food and Drug Administration has approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma, RCC) who have not responded to another drug for this type of cancer. Inlyta was also approved in Japan, Korea and other countries; however, it is still an investigational drug for adjuvant treatment for patients with high risk of recurrent RCC. It is investigational because the safety and efficacy of axitinib for the adjuvant treatment of kidney cancer has not yet been determined.

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