A Phase I/II Study Testing the Biologic Activity and Safety of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Stage IV Renal Cell Carcinoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 20
- Primary Endpoint
- 1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
Study Overview
Brief Summary
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer
Detailed Description
In this study, a new Immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a previous study (clinical protocol MB-002-003). While both processes are based on individual subject autologous tumor RNA and autologous monocyte derived DCs, the maturation of DCs in this newly modified process involves an altered regimen of culture with cytokines. In addition, huCD40L mRNA is added to the autologous expanded tumor total mRNA for electroporation. These changes promise a much improved migration, and activity profile of the DC-Immunotherapeutic product in RCC subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a new diagnosis of metastatic renal cell carcinoma;
- •Measurable disease
- •Must be at least 18 years or older;
- •Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
- •ECOG of 0 or 1;
- •Free of brain metastases by CT or MRI;
- •Normal renal function in contralateral kidney;
- •Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
- •Clinically acceptable screening results.
- •No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
- •No active autoimmune disease
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
Time Frame: 24 weeks
Secondary Outcomes
- Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression(24 weeks plus follow-up)