RNA-Loaded Dendritic Cell Cancer Vaccine

Argos Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Biological: MB-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087984

MB-002-003

Details and patient eligibility

About

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.

Enrollment: 26 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;
• Must be at least 18 years or older;
• Have a scheduled unilateral nephrectomy;
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

MB-002-003

Experimental group

Treatment:

Biological: MB-002