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Vaccine Therapy in Treating Patients With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004156
First Posted: May 20, 2004
Last Update Posted: October 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

Condition Intervention Phase
Breast Cancer Biological: MUC1-KLH vaccine/QS21 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination of High Risk Breast Cancer Patients With MUC-1 (Glycosylated) Keyhole Limpet Hemocyanin Conjugates Plus the Immunological Adjuvant QS21

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • immune response [ Time Frame: 2 years ]

Enrollment: 45
Study Start Date: May 1999
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine: MUC1-KLH vaccine/QS21
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.
Biological: MUC1-KLH vaccine/QS21

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Teresa Ann Gilewski, MD Memorial Sloan Kettering Cancer Center
  More Information

Publications:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00004156     History of Changes
Other Study ID Numbers: 99-023
CDR0000067394 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-H99-0043
First Submitted: December 10, 1999
First Posted: May 20, 2004
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I breast cancer
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
QS 21
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs