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
1 other identifier
interventional
26
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2004
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 16, 2004
CompletedFirst Posted
Study publicly available on registry
July 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFebruary 18, 2013
February 1, 2013
4.7 years
July 16, 2004
February 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
MB-002-003
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of California - Irvine
Orange, California, 92868, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2004
First Posted
July 20, 2004
Study Start
January 1, 2004
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 18, 2013
Record last verified: 2013-02