Vaccine Therapy in Treating Women With Metastatic Breast Cancer

NCT00003638 | Completed Phase 3

• 3 other identifiers: CDR0000066723BIOMIRA-STn-BR-104NCI-V98-1489
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether THERATOPE vaccine therapy is more effective than standard vaccine therapy in treating metastatic breast cancer. PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of THERATOPE vaccine therapy with that of standard vaccine therapy in treating women who have metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

Detox-B adjuvant BIOLOGICAL

THERATOPE STn-KLH vaccine BIOLOGICAL

keyhole limpet hemocyanin BIOLOGICAL

cyclophosphamide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oncothyreon Canada Inc.: lead

Study Sites (1)

Biomira Inc.

Edmonton, Alberta, AB T6N 1H1, Canada

Location

Related Publications (1)

• Ibrahim NK, Murray JL, Zhou D, Mittendorf EA, Sample D, Tautchin M, Miles D. Survival Advantage in Patients with Metastatic Breast Cancer Receiving Endocrine Therapy plus Sialyl Tn-KLH Vaccine: Post Hoc Analysis of a Large Randomized Trial. J Cancer. 2013 Aug 22;4(7):577-84. doi: 10.7150/jca.7028. eCollection 2013.

  PMID: 23983823 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

detox adjuvant; sialyl-Tn antigen-keyhole-limpet hemocyanin conjugate; keyhole-limpet hemocyanin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• BIOMIRA Customer Service (North America)

  Oncothyreon Canada Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 3, 2004
• Study Start: January 1, 1999
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2008
• Last Updated: March 26, 2013

Record last verified: 2008-12

Locations

CA (1)