Back to resultsRNA-Loaded Dendritic Cell Cancer Vaccine
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MB-002
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney cancer, Renal cancer
Eligibility 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
Sites / Locations
- University of California - Irvine
- Roswell Park Cancer Institute
- University of North Carolina at Chapel Hill
- Princess Margaret Hospital
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MB-002-003
Arm Description
Outcomes
Primary Outcome Measures
To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00087984
Brief Title
RNA-Loaded Dendritic Cell Cancer Vaccine
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Argos Therapeutics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Kidney cancer, Renal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MB-002-003
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MB-002
Intervention Description
Dendritic Cell Immunotherapy
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of California - Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.nkca.org
Description
Kidney Cancer Association
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RNA-Loaded Dendritic Cell Cancer Vaccine
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