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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02026960
Other study ID # Pro00047147
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date September 7, 2017

Study information

Verified date December 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date September 7, 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RNA extraction and amplification from biopsy specimens


Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Argos Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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