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Vaccination of High Risk Breast Cancer Patients Lacking Identifiable Disease With GM2-KLH Conjugate Plus the Immunological Adjuvant QS21

Phase 1
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Vaccination of High Risk Breast Cancer Patients Lacking Identifiable Disease With GM2-KLH Conjugate Plus the Immunological Adjuvant QS21

OBJECTIVES: I. Determine whether immunization with GM2-KLH vaccine plus the immunological
adjuvant QS21 induces an antibody response against GM2 and cells expressing GM2 in disease
free patients at high risk for recurrence of breast cancer.

OUTLINE: GM2-KLH vaccine plus QS21 is administered subcutaneously to sites on the upper arm
and upper leg at weekly intervals for 4 weeks. Two additional vaccines are administered at
weeks 12 and 24. Patients are followed every 3 months after the sixth vaccination.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Eligible patients must have no evidence of disease in addition to
1 of the following features: Stage I, II, or III breast cancer and have received adjuvant
chemotherapy and remain clinically free of identifiable disease, but have rising CA15.3
(BR2729) or CEA levels Stage III breast cancer and have completed adjuvant therapy no more
than 24 months ago Recurrence in the ipsilateral axilla following a lumpectomy/axillary
dissection or modified radical mastectomy Recurrence in the ipsilateral breast following a
lumpectomy/axillary dissection Stage II breast cancer with at least 4 positive axillary
lymph nodes at 24 months following completion of adjuvant therapy Patients with isolated
elevation of the CEA level must have a colonoscopy to rule out colon carcinoma A
colonoscopy within the past 5 years is acceptable if there is no strong family history of
colon carcinoma, colonic polyps, or inflammatory bowel disease Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Premenopausal or
postmenopausal Performance status: Karnofsky 90-100% Life expectancy: Not specified
Hematopoietic: Lymphocyte count at least 500/mm3 WBC count at least 3,000/mm3 Hepatic:
Aspartate aminotransferase no greater than 1.5 times upper limit of normal (ULN) Alkaline
phosphatase 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 cardiac disease Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No other concurrent active cancers except basal cell or squamous cell
carcinomas of the skin No history of a seafood allergy No known history of
immunodeficiency or autoimmune disease

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Teresa Ann Gilewski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 1998

Completion Date:

November 2001

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage III breast cancer
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021