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RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)

Primary Purpose

Metastatic Renal Cell Carcinoma, Genitourinary Cancer (Bladder, Prostate or Testicular)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RNA extraction and amplification from biopsy specimens
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:

  1. 18 years of age or older.
  2. Suspected RCC, in the opinion of the investigator

  3. Availability of either:

    • Nephrectomy or other surgically removed tissue (Stage I); or,
    • Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).

  4. ≥5 biopsy specimens available from BRPC.

    • Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
  5. Not currently being treated with systemic therapy.

Exclusion Criteria:

  1. Tumor tissue is committed to other use or inadequate for RNA analysis.
  2. Insufficient tissue is collected in the BRPC.

Expansion Cohort for Genitourinary Cancers:

Inclusion Criteria:

  1. 18 years of age or older
  2. Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
  3. Availability of surgically removed tissue or biopsy tissue.
  4. At least 2 biopsy specimens available from BRPC
  5. Not currently being treated with systemic therapy.

Exclusion Criteria:

  1. Tumor tissue is committed to other use or inadequate for RNA analysis.
  2. Insufficient tissue is collected in the BRPC.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Renal Cell Carcinoma Tumor Tissue

Genitourinary tumor tissue (Expansion cohort)

Arm Description

Bladder, prostate or testicular cancer

Outcomes

Primary Outcome Measures

Success rate for tumor RNA isolation and amplification
To Determine the success rate for tumor RNA isolation and amplification create a minimum of 10 doses of AGS-003, as defined by a minimum concentration of ≥84 µg/µL in typically greater than 150 µL final volume RNA. (Tissue obtained at time of surgery or biopsy depending on stage)

Secondary Outcome Measures

Full Information

First Posted
January 2, 2014
Last Updated
December 19, 2018
Sponsor
Duke University
Collaborators
Argos Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02026960
Brief Title
RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
Official Title
RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
The sponsor's clinical program for the agent used in this study was discontinued.
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Argos Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma, Genitourinary Cancer (Bladder, Prostate or Testicular)

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Cell Carcinoma Tumor Tissue
Arm Type
Experimental
Arm Title
Genitourinary tumor tissue (Expansion cohort)
Arm Type
Experimental
Arm Description
Bladder, prostate or testicular cancer
Intervention Type
Device
Intervention Name(s)
RNA extraction and amplification from biopsy specimens
Primary Outcome Measure Information:
Title
Success rate for tumor RNA isolation and amplification
Description
To Determine the success rate for tumor RNA isolation and amplification create a minimum of 10 doses of AGS-003, as defined by a minimum concentration of ≥84 µg/µL in typically greater than 150 µL final volume RNA. (Tissue obtained at time of surgery or biopsy depending on stage)
Time Frame
At time of surgery or during biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply: 18 years of age or older. Suspected RCC, in the opinion of the investigator Availability of either: Nephrectomy or other surgically removed tissue (Stage I); or, Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II). ≥5 biopsy specimens available from BRPC. Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol. Not currently being treated with systemic therapy. Exclusion Criteria: Tumor tissue is committed to other use or inadequate for RNA analysis. Insufficient tissue is collected in the BRPC. Expansion Cohort for Genitourinary Cancers: Inclusion Criteria: 18 years of age or older Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator. Availability of surgically removed tissue or biopsy tissue. At least 2 biopsy specimens available from BRPC Not currently being treated with systemic therapy. Exclusion Criteria: Tumor tissue is committed to other use or inadequate for RNA analysis. Insufficient tissue is collected in the BRPC.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harrison, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)

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