Renal Cell Carcinoma Clinical Trial
Official title:
A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma
Verified date | February 2013 |
Source | Argos Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Princess Margaret Hospital | Toronto | Ontario |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | University of California - Irvine | Orange | California |
Lead Sponsor | Collaborator |
---|---|
Argos Therapeutics |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma. | From registration until disease progression or withdrawal from study | Yes | |
Primary | To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval). | From registration until disease progression or withdrawal from study | No |
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