Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate C... | NCT00040170

Studies
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer

NCT00040170

Sponsor

Transgene

Status

Terminated

Last Update Posted

Nov 2, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Prostatic Neoplasms

Interventions

MVA-MUC1-IL2

Countries

United States

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

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 21, 2002

First Submission Date that Met QC Criteria

Jun 24, 2002

First Posted Date

Jun 25, 2002Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2006

Last Update Posted Date

Nov 2, 2006Estimated

Name	Class
University of California, Los Angeles	OTHER
The Cleveland Clinic	OTHER
University of Arizona	OTHER

Description Module

Brief Summary

This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.

Detailed Description

The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer cells. The second gene is for human interleukin 2 (IL2) which the body's immune system makes to help it fight cancer. The TG4010 is given as an injection under the skin (subcutaneous) once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve (12) weeks. If the therapy is working, it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
MVA-MUC1-IL2	Biological

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

Metastasis or local disease
Prior hormone treatment

Accepts Healthy Volunteers

Sex

Male

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

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Cancer Center		Tucson	Arizona	85724	United States
UCLA

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided