Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients

January 22, 2008 updated by: Oncothyreon Canada Inc.

Open-Label, Phase II Trial of Immunological Response Rate, Safety, and Tolerability of THERATOPE® Vaccine in Subjects With Metastatic Breast Cancer Undergoing Treatment With Aromatase Inhibitors or Faslodex®

The purpose of this study is to examine the immunological response rate to administration of the THERATOPE® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or Faslodex® and who do not require chemotherapy.

Post-menopausal women on aromatase inhibitors or Faslodex® alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone (LH/RH)-agonist may be eligible to be enrolled.

Patients must not have had radiotherapy or major surgery within four (4) weeks prior to entering the study.

Information about the safety and tolerability of administration of the THERATOPE® vaccine will also be gathered during the course of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States
      • San Francisco, California, United States
      • Santa Monica, California, United States
    • Florida
      • Jacksonville, Florida, United States
      • Plantation, Florida, United States
      • Port St. Lucie, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Montana
      • Billings, Montana, United States
    • New Jersey
      • Morristown, New Jersey, United States
    • North Carolina
      • Gastonia, North Carolina, United States
      • Hickory, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Histopathologically confirmed breast cancer
  • Documented Stage IV disease
  • Estrogen and/or progesterone-receptor positive
  • Stable disease on aromatase inhibitor or Faslodex® treatment begun at least 12 weeks prior to enrolment
  • Performance status, ECOG = 0 or 1
  • Life expectancy > 12 weeks
  • History of freedom from progression for at least 6 months following surgery with a curative intent or for at least 6 months during adjuvant chemotherapy, adjuvant radiotherapy or adjuvant hormonal therapy such as tamoxifen/toremifene treatment
  • No radiotherapy or major surgery within 4 weeks prior to enrolment

Exclusion Criteria

  • Pregnant or lactating
  • Known brain metastasis
  • Bone marrow involvement as the only site of metastasis
  • First line chemotherapy for Stage IV disease
  • Past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of disease
  • Autoimmune disease, e. g., type I juvenile onset diabetes mellitus, antibody positive rheumatoid arthritis, Grave's disease, lupus, Crohn's disease, IBD, Hashimoto's thyroiditis
  • Known intercurrent infections (including HBV or HCV) or immunosuppression [human immunodeficiency virus (HIV) or other conditions] or clinical evidence of these conditions
  • Other significant active infection
  • Pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently
  • Splenectomy
  • Concurrent treatment with chemotherapeutic agents other than low-dose cyclophosphamide used in this study
  • Treatment with interferons (IFNs), cytokines, systemic steroids or other biologicals within 4 weeks prior to enrolment
  • Receipt of another investigational drug within 30 days of enrolment
  • Known allergy to shellfish
  • Known allergy to soy beans or soy products
  • Known hypersensitivity to polysorbate 80
  • Known hypersensitivity to the study drugs
  • Legal incapacity or limited legal capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncothyreon Canada Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion

December 6, 2022

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 27, 2002

First Submitted That Met QC Criteria

October 9, 2002

First Posted (Estimate)

October 10, 2002

Study Record Updates

Last Update Posted (Estimate)

January 23, 2008

Last Update Submitted That Met QC Criteria

January 22, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STn-BR-105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on THERATOPE® vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe