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

Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00040170

Enrollment

Registered

2002-06-25

Start date

2002-05-31

Completion date

Unknown

Last updated

2006-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

Adenocarcinoma of the prostate

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.

Interventions

BIOLOGICALMVA-MUC1-IL2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Rising PSA after surgery or radiation for prostate cancer

Exclusion criteria

* Metastasis or local disease * Prior hormone treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026