Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients
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®
1 other identifier
interventional
N/A
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2002
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 27, 2002
CompletedFirst Posted
Study publicly available on registry
October 10, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJanuary 23, 2008
January 1, 2008
September 27, 2002
January 22, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Berkeley, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Port Saint Lucie, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Billings, Montana, United States
Unknown Facility
Morristown, New Jersey, United States
Unknown Facility
Gastonia, North Carolina, United States
Unknown Facility
Hickory, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2002
First Posted
October 10, 2002
Study Start
August 1, 2002
Study Completion
August 1, 2005
Last Updated
January 23, 2008
Record last verified: 2008-01