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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: RNA extraction and amplification from biopsy specimens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Cell Carcinoma Tumor Tissue<br> | Device: RNA extraction and amplification from biopsy specimens<br> <br> |
| Experimental: Genitourinary tumor tissue (Expansion cohort)<br>Bladder, prostate or testicular cancer | Device: RNA extraction and amplification from biopsy specimens<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At time of surgery or during biopsy |