Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer

Argos Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Renal Cell Carcinoma

Treatments

Biological: AGS-003

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272649

White-04-05-01A

Figlin-05-03-099-01

AGS-003-004

Drabkin-05-0167

Logan-0506-05

Bukowski-8077

Details and patient eligibility

About

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

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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