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
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Biological: MB-002
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Argos Therapeutics:

Primary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: January 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MB-002-003 Biological: MB-002
Dendritic Cell Immunotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087984

Locations
United States, California
University of California - Irvine
Orange, California, United States, 92868
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
Argos Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT00087984     History of Changes
Other Study ID Numbers: MB-002-003
Study First Received: July 16, 2004
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Argos Therapeutics:
Kidney cancer
Renal cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014