Genitourinary Cancer (Bladder, Prostate or Testicular), Metastatic Renal Cell Carcinoma
Conditions
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.
Interventions
DEVICERNA extraction and amplification from biopsy specimens
Sponsors
Argos Therapeutics
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate for tumor RNA isolation and amplification | At time of surgery or during biopsy | 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) |
Countries
United States
Outcome results
None listed