Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT02170389|
Recruitment Status : Terminated (sponsor having financial difficulties)
First Posted : June 23, 2014
Results First Posted : January 6, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Renal Cell Carcinoma Stage I Renal Cell Cancer Stage II Renal Cell Cancer||Other: Laboratory Biomarker Analysis Procedure: Nephrectomy Biological: Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003||Not Applicable|
I. To assess the immune-modulatory systemic and intratumoral effects of AGS-003 (renal cell carcinoma/cluster of differentiation [CD]40L ribonucleic acid [RNA]-transfected autologous dendritic cell vaccine AGS-003) as neoadjuvant treatment in patients with localized renal cell carcinoma.
I. To assess the feasibility that total tumor RNA processing-related activities meet specifications for AGS-003 manufacturing utilizing a core needle biopsy procedure for tumor harvesting prior to nephrectomy.
Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 intradermally (ID) once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.
After completion of study treatment, patients are followed up at 1 month.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant AGS-003 Immunotherapy in Patients With Localized Kidney Cancer <pT2|
|Actual Study Start Date :||October 14, 2014|
|Actual Primary Completion Date :||March 17, 2017|
|Actual Study Completion Date :||March 17, 2017|
Experimental: Treatment (AGS-003 immunotherapy, nephrectomy)
Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.
Other: Laboratory Biomarker Analysis
Undergo partial or radical nephrectomy
Biological: Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003
Other Name: AGS-003
- Change in Immune Marker Expression Levels [ Time Frame: Baseline to up to 30 days post-nephrectomy ]
The time component will be modeled as a three-level classification factor. The full model for the effects of time will be fit using linear mixed model methods. The model will include a random patient effect and 5 fixed effects for time and the interactions. The presence of any time effect will be assessed with full-reduced model type 3 test. If the omnibus test is statistically significant at the p < 0.05 level, then three pairwise time-point comparisons will be conducted.
Expression measurements may be transformed to satisfy modeling assumptions.
- Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 30 days ]Summarized in all patients who received AGS-003. These rates will be described as the proportion of patients with the event, by grade, and supported with exact 95% confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170389
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Dr. med.Thomas Schwaab, MD||Roswell Park Cancer Institute|