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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

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Trial Information

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


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.


Inclusion Criteria:



- Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

- Metastasis or local disease

- Prior hormone treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TG4010.03

NCT ID:

NCT00040170

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Prostatic Neoplasms
  • Adenocarcinoma of the prostate
  • Adenocarcinoma
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Cleveland Clinic FoundationCleveland, Ohio  44195
UCLALos Angeles, California  90095