This research trial studies ways to obtain ribonucleic acid (RNA) from tissue samples from patients with kidney cancer or any genitourinary (bladder, prostate, or testicular) cancers undergoing surgery or biopsy so that it can be used to make immunotherapy treatments. Immunotherapy uses cells from the body's own immune system to attack cancer cells, either with treatments that stimulate the immune system to attack cancer cells, or by modifying a person's own immune cells so that they attack cancer cells. A patient's tumor RNA can be taken from tumor tissue samples and used to modify immune cells so that they are programmed to target the tumor. Studying the best way to take RNA from tissue samples may help doctors to design vaccines made from genetically-modified tumor cells to treat patients with kidney or other genitourinary cancers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02026960.
PRIMARY OBJECTIVES:
I. To evaluate methods for autologous amplified tumor RNA electroporated monocyte-derived dendritic cells matured with the post-maturation electroporation (PME)-cluster of differentiation (CD) 40 ligand (L) process (AGS-003) production from surgical (stage I) and metastatic biopsy (stage II) renal cell carcinoma (RCC) and a small subset of other genitourinary (GU) cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers.
II. Evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.
OUTLINE:
STAGE I: Patients with RCC undergo tissue sample collection as core needle specimens from surgical resection for RNA extraction and amplification.
STAGE II: Patients with RCC undergo tissue sample collection using actual core needle biopsy for RNA extraction and amplification.
EXPANSION COHORT: Patients with GU cancers undergo tissue sample collection as in Stages I and II for RNA extraction and amplification.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationDuke University Medical Center
Principal InvestigatorMichael R. Harrison