RNA-Loaded Dendritic Cell Cancer Vaccine | NCT00087984

Studies
RNA-Loaded Dendritic Cell Cancer Vaccine

NCT00087984

Sponsor

Argos Therapeutics

Status

Completed

Last Update Posted

Feb 18, 2013Estimated

Enrollment

26Actual

Phase

Phase 1Phase 2

Conditions

Renal Cell Carcinoma

Interventions

MB-002

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jul 16, 2004

First Submission Date that Met QC Criteria

Jul 19, 2004

First Posted Date

Jul 20, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 22, 2013

Certification/Extension First Submitted that Passed QC Review

Feb 14, 2013

Certification/Extension First Posted Date

Feb 18, 2013Estimated

Last Update Submitted Date

Feb 14, 2013

Last Update Posted Date

Feb 18, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MB-002-003	Experimental		Biological: MB-002

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MB-002	Biological	Dendritic Cell Immunotherapy	MB-002-003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California - Irvine		Orange	California	92868	United States
Roswell Park Cancer Institute

Label	URL
Kidney Cancer Association	View source

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided