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

Transgene

Status and phase: Terminated; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Biological: MVA-MUC1-IL2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00040170

TG4010.03

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rising PSA after surgery or radiation for prostate cancer

Exclusion criteria

• Metastasis or local disease
• Prior hormone treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)