RNA-Loaded Dendritic Cell Cancer Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT00087984
First received: July 16, 2004
Last updated: February 14, 2013
Last verified: February 2013

July 16, 2004
February 14, 2013
January 2004
September 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00087984 on ClinicalTrials.gov Archive Site
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RNA-Loaded Dendritic Cell Cancer Vaccine
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
Biological: MB-002
Dendritic Cell Immunotherapy
Experimental: MB-002-003
Intervention: Biological: MB-002
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00087984
MB-002-003
Not Provided
Argos Therapeutics
Argos Therapeutics
Not Provided
Not Provided
Argos Therapeutics
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP