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

This study has been completed.
Sponsor:
Information provided by:
Oncothyreon Canada Inc.
ClinicalTrials.gov Identifier:
NCT00046371
First received: September 27, 2002
Last updated: January 22, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: THERATOPE® vaccine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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®

Resource links provided by NLM:


Further study details as provided by Oncothyreon Canada Inc.:

Study Start Date: August 2002
Study Completion Date: August 2005
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046371

Locations
United States, California
Berkeley, California, United States
San Francisco, California, United States
Santa Monica, California, United States
United States, Florida
Jacksonville, Florida, United States
Plantation, Florida, United States
Port St. Lucie, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Montana
Billings, Montana, United States
United States, New Jersey
Morristown, New Jersey, United States
United States, North Carolina
Gastonia, North Carolina, United States
Hickory, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
Sponsors and Collaborators
Oncothyreon Canada Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046371     History of Changes
Other Study ID Numbers: STn-BR-105
Study First Received: September 27, 2002
Last Updated: January 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Oncothyreon Canada Inc.:
Cancer Vaccines
Aromatase
Receptors, Estrogen
Receptors, Progesterone

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014