Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies

• Status: Completed
• Trial end date: 2021-06-29
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this research is to evaluate response to systemic therapy, including anti-angiogenesis therapy and/or immune-based therapies via 18F-DCFPyL prostate-specific membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) in patients with metastatic renal cell carcinoma (RCC) and to compare qualitatively with conventional imaging response criteria - Response Evaluation Criteria In Solid Tumors (RECIST 1.1) and histopathological endpoints including isolation, enumeration and staining of Circulating Tumor Cells (CTC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Patients diagnosed with locally advanced (>/=cT3) or metastatic clear cell RCC as proven by biopsy.

• Adults, 18 years of age or older.

• Surgical candidates who have clinical indication for nephrectomy and standard-of-care biopsy of metastatic disease followed by possible standard of care systemic anti-angiogenesis based treatment regimen

• Have consented to participate in the University of Wisconsin Carbone Cancer Center Biobank.

Exclusion Criteria:

• Patients who have received prior RCC systemic therapies

• Prior history of prostate cancer

• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer

• Unable to lie flat during or tolerate PET/CT

• Serum creatinine > 2 times the upper limit of normal