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

NCT03387514 | Terminated Phase 2 Results DMC FDA Drug

• 5 other identifiers: 2017-1343P30CA014520A539300SMPH/RADIOLOGY/RADIOLOGY*Protocol Version 4/22/2019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Renal Cell Carcinoma

Keywords

Clear Cell; Kidney Cancer; RCC

Outcome Measures

Primary Outcomes (4)

• Baseline Tumor FDG PET SUV Data by Disease Type at Baseline

  Tumor FDG PET SUV data is provided from baseline PET tumor data. Participants with baseline 18F-DCFPyL PSMA PET/CT prior to surgical nephrectomy and metastatic disease sampling were analyzed based single timepoints for PET SUVmax values of tumor uptake (primary and metastatic disease)

  Baseline

• Histopathological Endpoints: Immunohistochemical Staining for PSMA

  Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)

  Up to 24 months

• Histopathological Endpoints: Tumor Vascular Density

  Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)

  Up to 24 months

• Histopathological Endpoints: Neovascularization Measured by CD105 and CD31 Markers

  Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)

  Up to 24 months

Secondary Outcomes (4)

• Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): Vessel Sprouting

  Up to 24 months

• Evaluate the Predictive Power and Validate the uVESSEL Model

  Up to 24 months

• Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): PMSA Expression

  Up to 24 months

• Measure Therapy Response of Patient Specific uVESSEL (a Micro Scale Organotypic Co-culture Model): Cell Death

  Up to 24 months

Study Arms (1)

18F-DCFPyL whole body PET/CT scan

EXPERIMENTAL

18F-DCFPyL whole body PET/CT scan at three time-points

Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams

Interventions

PSMA-based 18F-DCFPyL PET tracer for PET/CT exams DRUG

18F-DCFPyL whole body PET/CT scan administered at the following timepoints: PET1 - Prior to scheduled nephrectomy PET2 - to establish a new baseline PET before systemic therapy * PET2A - Post-surgery and prior to start of standard of care systemic therapy * PET2B - 12-16 weeks from start of first line systemic therapy (immune-based or anti-angiogenic) PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy * PET3A - Prior to start of additional anti-angiogenesis therapy * PET3B - 12-16 weeks from the start of additional anti-angiogenesis therapy PET4 - obtained at clinical progression or 2 years following initial systemic therapy

Also known as: PSMA PET

18F-DCFPyL whole body PET/CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Limitations and Caveats

Due to change in standard of care system therapy to immune therapy during the course of this trial, patients did not proceed to anti-angiogenesis therapy or combined anti-angiogenesis therapy with immune therapy to allow for further PET or CT maging timepoints during the follow-up period of this trial. Therefore RECIST 1.1 response could not be assessed but PET SUVmax data is provided. Due to low enrollment for this issue, the study funding did not continue to allow for further study data.

Results Point of Contact

• Title: Steve Cho, MD
• Organization: UW School of Medicine and Public Health

cho85@wisc.edu

608-263-5585

Study Officials

• Steve Cho, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single cohort study without randomization or stratification.

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: December 8, 2018
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: December 21, 2022
• Results First Posted: December 21, 2022

Record last verified: 2022-12

Locations

US (1)