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Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies (UW17104)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03387514
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : October 1, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams Phase 2

Detailed Description:

Response of systemic therapy, including anti-angiogenesis therapy and/or immune-based therapies will be quantified using PSMA-based PET imaging using a novel agent,18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature to functionally monitor renal cell cancer neovasculature in patients undergoing systemic anti-angiogenesis therapy. PSMA PET will be compared with response to anti-angiogenesis therapy using conventional imaging computed tomography(CT)-based RECIST1.1 criteria as well as histopathological endpoints (tumor vascular density, immunohistochemical staining for PSMA and neovascularization (cluster of differentiation(CD)105, CD31). Whole body PSMA PET/CT scans will be obtained at baseline, following adjuvant anti- angiogenic therapy and when the patient becomes refractory to treatment.

The rationale and time points for obtaining PET scans is planned with respect to the typical natural history of metastatic RCC. This project will obtain information from tumors that are responding to anti-angiogenesis therapy and those resistant to treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a single cohort study without randomization or stratification.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : June 29, 2021
Actual Study Completion Date : June 29, 2021


Arm Intervention/treatment
Experimental: 18F-DCFPyL whole body PET/CT scan
18F-DCFPyL whole body PET/CT scan at three time-points
Drug: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams

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

Other Name: PSMA PET




Primary Outcome Measures :
  1. RECIST 1.1 Based Criteria [ Time Frame: Up to 24 months ]
    Compare number of lesions identified on PSMA versus standard of care imaging base on RECIST 1.1 criteria.

  2. HIstopathological Endpoints [ Time Frame: Up to 24 months ]
    Compare PSMA imaging to histopathological endpoints which include tumor vascular density, immunohistochemical staining for PSMA and neovascularization (CD105, CD31 markers)


Secondary Outcome Measures :
  1. Measure therapy response of patient specific uVESSEL (a micro scale organotypic co-culture model) [ Time Frame: Up to 24 months ]
    Patient-derived uVESSEL models (from primary & metastatic sites) and incorporating patient-derived immune cells, will be tested for response to anti-angiogenic therapies including pazopanib, sunitinib, cabozantinib, and axitinib. Response will be quantified via multiple endpoints, e.g. vessel sprouting, PSMA expression, cell death.

  2. Evaluate the predictive power and validate the uVESSEL model [ Time Frame: Up to 24 months ]
    Using the clinical, pathological and imaging endpoints, predictive models will e developed using responses to uVESSEL model above. More specifically the objective response (dichotomous endpoint of yes or no) measured using PSMA-based PET/CT will be used as a dependent variable in a logistic regression model with response to uVESSEL model from above as an independent predictor to segregate uVESSEL responses into two groups corresponding to responders and non-responders to anti-angiogenic therapies.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387514


Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steve Cho, MD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03387514    
Other Study ID Numbers: 2017-1343
P30CA014520 ( U.S. NIH Grant/Contract )
A539300 ( Other Identifier: UW Madison )
SMPH/RADIOLOGY/RADIOLOGY* ( Other Identifier: UW Madison )
Protocol Version 4/22/2019 ( Other Identifier: UW Madison )
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Clear Cell
Kidney Cancer
RCC
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases