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RNA-Loaded Dendritic Cell Cancer Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00087984
Recruitment Status : Completed
First Posted : July 20, 2004
Last Update Posted : February 18, 2013
Information provided by (Responsible Party):
Argos Therapeutics

July 16, 2004
July 20, 2004
February 18, 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 ]
  • 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 ]
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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.
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Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
Biological: MB-002
Dendritic Cell Immunotherapy
Experimental: MB-002-003
Intervention: Biological: MB-002
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Argos Therapeutics
Argos Therapeutics
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Argos Therapeutics
February 2013

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