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

This study has been terminated.
Sponsor:
Collaborators:
University of California, Los Angeles
The Cleveland Clinic
University of Arizona
Information provided by:
Transgene
ClinicalTrials.gov Identifier:
NCT00040170
First received: June 21, 2002
Last updated: October 31, 2006
Last verified: October 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
 Biological: MVA-MUC1-IL2
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Transgene:

Estimated Enrollment: 50
Study Start Date: May 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

  • Metastasis or local disease
  • Prior hormone treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040170

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Transgene
University of California, Los Angeles
The Cleveland Clinic
University of Arizona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040170     History of Changes
Obsolete Identifiers: NCT00040976
Other Study ID Numbers: TG4010.03
Study First Received: June 21, 2002
Last Updated: October 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Transgene:
Adenocarcinoma of the prostate

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
 Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013