A Multi-Center Phase III Randomized, Controlled Study of Theratope Vaccine for Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Multi-Center Phase III Randomized, Controlled Study of Theratope Vaccine for Metastatic Breast Cancer
OBJECTIVES: I. Compare time to disease progression in patients receiving THERATOPE vaccine
to that of women receiving control vaccine. II. Compare survival in patients receiving
THERATOPE vaccine to that of patients receiving control vaccine. III. Document the product
safety profile in these patients. IV. Measure the anti-STn, anti-OSM, and anti-KLH antibody
titers. V. Evaluate the impact of THERATOPE STn-KLH vaccine on health-related quality of
life in these patients.
OUTLINE: The study design is a prospective, double-blinded, randomized study. Patients who
have completed first-line chemotherapy for metastatic breast cancer and have either
nonprogressive disease or no evidence of disease following completion of first-line
chemotherapy (includes bone marrow transplants and stem cell rescue) will be randomized to
either the THERATOPE vaccine or the control vaccine. Patients are stratified at entry
according to disease status (i.e., either no evidence of disease or nonprogressive disease)
and whether or not they are receiving hormonal therapy for metastatic disease while on
study. Arm I: Patients receive intravenous cyclophosphamide on day -3, followed by 4
subcutaneous vaccinations with THERATOPE STn-KLH vaccine combined with Detox-B Stable
Emulsion at 0, 2, 5, and 9 weeks. Arm II: Patients receive the control treatment of
intravenous cyclophosphamide on day -3, followed by 4 subcutaneous vaccinations with keyhole
limpet hemocyanin (KLH) vaccine combined with Detox-B Stable Emulsion at 0, 2, 5, and 9
weeks. Patients with stable or responding disease may receive the THERATOPE STn-KLH vaccine
or control without Detox-B Stable Emulsion at weeks 13, 17, 21, and 25. Patients without
unacceptable toxic effects or disease progression may continue on maintenance therapy at 3
month intervals.
PROJECTED ACCRUAL: Over 120 sites in North America, Europe, and Australia/New Zealand will
be participating in the study. A total of 950 women (475 per treatment arm) will be enrolled
into the study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven breast cancer Must be
enrolled no later than 40 weeks from the start of first line chemotherapy for metastatic
disease High dose chemotherapy with bone marrow transplantation or stem cell rescue as
part of first line therapy is allowed Either no evidence of disease or nonprogressive
disease following first line chemotherapy Patients receiving concurrent hormonal therapy
are eligible Patients with bone metastases as the only site of disease are eligible No
known brain metastases (patients with stable brain metastases for greater than 6 months
may be allowed if not on concurrent corticosteroids) No locoregional disease as the only
evidence of metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil
count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL
Hepatic: SGOT or SGPT no greater than 2.0 times upper limit of normal (ULN) (less than 5
times ULN with liver metastases) Bilirubin no greater than 2.0 times ULN Renal: Creatinine
no greater than 2.0 times ULN Cardiovascular: No significant cardiac disease No myocardial
infarction within 1 year of study No uncontrolled arrhythmias No uncontrolled hypertension
No congestive heart failure Pulmonary: Not specified Other: Not pregnant or nursing
Fertile patients must use effective contraception Negative pregnancy test No prior
malignancies within the past 5 years, except: Curatively treated nonmelanoma skin cancer
Carcinoma in situ of the cervix No autoimmune disease (e.g., systemic lupus erythematosus,
ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis,
rheumatoid arthritis) No immunodeficiency disease (cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital
immunodeficiencies) Controlled Type II diabetes allowed No clinically significant active
infection No known allergy to shellfish No known allergy to soy beans and/or soy products
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferons,
tumor necrosis factor, other cytokines or biologic response modifiers, BCG vaccines, or
therapeutic monoclonal antibodies Chemotherapy: See Disease Characteristics Must have
completed first line chemotherapy for metastatic disease At least 3 weeks since prior
chemotherapy Endocrine therapy: No concurrent corticosteroid, cyclosporine, or
adrenocorticotropic hormone therapy Radiotherapy: At least 3 weeks since radiation therapy
Surgery: At least 4 weeks since prior surgery requiring general anesthetic No splenectomy
Other: At least 4 weeks since other investigational drugs Concurrent bisphosphonate
therapy allowed provided therapy was initiated more than 3 weeks prior to study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
BIOMIRA Customer Service (North America)
Investigator Role:
Study Chair
Investigator Affiliation:
Oncothyreon Canada Inc.
Authority:
United States: Federal Government
Study ID:
CDR0000066723
NCT ID:
NCT00003638
Start Date:
January 1999
Completion Date:
December 2008
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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