RNA-Loaded Dendritic Cell Cancer Vaccine

Argos Therapeutics26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma

Interventions

MB-002BIOLOGICAL

Dendritic Cell Immunotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University of California - Irvine

Orange, California, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.

Time frame: From registration until disease progression or withdrawal from study

To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).

Time frame: From registration until disease progression or withdrawal from study

Data from ClinicalTrials.gov

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