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Vaccine Therapy in Treating Patients With Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004156
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: MUC1-KLH vaccine/QS21
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: QS 21
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Vaccination of High Risk Breast Cancer Patients With MUC-1 (Glycosylated) Keyhole Limpet Hemocyanin Conjugates Plus the Immunological Adjuvant QS21

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1999
Detailed Description:

OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with high risk breast cancer expressing MUC-1.

OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, and 19 for a total of 5 vaccinations. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS: Diagnosed breast cancer at high risk for disease recurrence with one of the following requirements: Disease free stage IV breast cancer following eradication of disease by surgery, radiotherapy, or chemotherapy Stage I, II, or III breast cancer remaining clinically free of identifiable disease following adjuvant chemotherapy with 2 consecutively rising CA15.3 (BR2729) or CEA levels at least 2 weeks apart Elevation of marker levels not needed for stage III disease if adjuvant therapy completed within past 2 years CEA increase at least 1.5 times upper chronic value in patients with significant smoking history and chronic CEA elevation less than 15 Recurrence in the ipsilateral axilla following lumpectomy/axillary dissection or modified radical mastectomy Recurrence in the ipsilateral breast following lumpectomy/axillary dissection Stage II disease with at least 4 positive axillary lymph nodes and adjuvant therapy completed within past 2 years Stable stage IV disease on hormonal therapy Colonoscopy required for isolated CEA elevation Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 90-100% Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 500/mm3 WBC at least 3,000/mm3 Hepatic: Alkaline phosphatase no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No immunodeficiency or autoimmune disease No seafood allergies No other active malignancies except basal cell or squamous cell skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004156

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Teresa Ann Gilewski, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067394, MSKCC-99023, NCI-H99-0043
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004156     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Study placed in the following topic categories:
Immunologic Factors
Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
QS 21
Keyhole-limpet hemocyanin
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Breast Neoplasms
QS 21
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009