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

NCT ID: NCT00040170

Last Updated: 2006-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms

Keywords

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Adenocarcinoma of the prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MVA-MUC1-IL2

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria

* Metastasis or local disease
* Prior hormone treatment
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role collaborator

Transgene

INDUSTRY

Sponsor Role lead

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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TG4010.03

Identifier Type: -

Identifier Source: org_study_id

NCT00040976

Identifier Type: -

Identifier Source: nct_alias