Clinical Trials

• Vaccination of Patients with Renal Cancer with Dendritic Cell/Tumor Fusions and GM-CSF (DF/HCC 04-117). A Phase II trial for untreated patients who present with metastatic disease and primary tumor in place; patients receive a series of vaccinations using fusions of autologous dendritic cells and tumor cells obtained from the debulking nephrectomy specimen and GM-CSF (SPORE Project 5). 
   
• The High-dose Aldesleuken (IL-2)"SELECT" Trial: A Trial Designed to Prospectively Validate Models of Response to High Dose IL-2 Treatment in Patients with Metatastic Renal Cell Carcinoma (DF/HCC 06-149).
    

• Phase I/II trial of Sorafenib in combination with bevacizumab in patients with advanced renal cancer (DF/HCC 04-393). Investigator-initiated CTEP-sponsored trial of a VEGFR/PDGFR inhibitor (Sorafenib) and a VEGF neutralizing antibody (Avastin) in patients with metastatic RCC. Patients receive escalating doses of these targeted therapies in the Phase I portion of the study.

• Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Porr-Risk Patients with Metastatic Renal Cell Carcinoma (DF/HCC 07-212).

• An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer (DF/HCC 08-034).

• A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma (DF/HCC 08-184).

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  Adjuvant Therapy

•  A Randomized, Double Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma (DF/HCC 06-225). To be eligible, patients must have histological or cytological confirmed renal cell carcinoma T1B (Fuhrman grade 3-4), T2, T3 and T4 with N0-2 and must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) by either open or laparoscopic technique and enroll within 10 weeks of radical or partial nephrectomy. 

  Laboratory Correlates

• Collection of specimen and clinical data from patients with renal cell carcinoma treated with Target Therapies (DF/HCC 06-105). Analysis of discarded tissue in patients with renal cell carcinoma undergoing either nephrectomy or resection of metastatic disease. Tumor tissue is stored in our tissue bank to be analyzed by gene expression profiling and various immunohistochemical and RT-PCR techniques in an effort to discover new prognostic factors, predictors of response and resistance, and new therapeutic targets.

• Collection of specimen and clinical data from patients with renal cell carcinoma (DF/HCC 01-130).  Tissue banking and database protocol (SPORE Path CORE)

David McDermott, MD, Chair (BIDMC)
Michael B. Atkins, MD (BIDMC)
Dror Michaelson, MD PhD (MGH)
Daniel Cho, MD (BIDMC)
Toni Choueiri, MD (DFCI)

This service is available to patients and families at all our participating institutions.  For more information, please call our Patient-to-Patient coordinator at 617-632-9270