Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	MSKCC-01019 NCI-H01-0084, NCT00030823

Objectives

1. Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y, TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence.
2. Determine the toxic effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:
  • Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy
    • May or may not have elevated CA 15-3 or CEA levels
  • Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels
    • Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart
      • For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart
  • Stage III and completed adjuvant therapy no more than 24 months ago
  • Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy
  • Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection
  • Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago
  • Stage IV that is stable on hormonal therapy



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• At least 6 weeks since prior immunotherapy
• No prior vaccine with any of the antigens in this study

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
• Concurrent surgery for local recurrence allowed if patient remains disease free

Patient Characteristics:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Lymphocyte count at least 500/mm³
• WBC at least 3,000/mm³

Hepatic:

• AST 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 clinically significant New York Heart Association class III or IV cardiac disease

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior seafood allergy
• No known prior immunodeficiency or autoimmune disease
• No other active cancer except basal cell or squamous cell skin cancer

Expected Enrollment

A total of 30 patients will be accrued for this study within 2-3 months.

Outline

Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.

Patients are followed every 3 months.

Armstrong JL, Ragupathi G, Powell S, et al.: Preliminary data of vaccination of high risk breast cancer (BC) patients (pts) with a heptavalent antigen: keyhole limpet hemocyanin (KLH) conjugate plus the immunologic adjuvant QS-21. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-675, 2003.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Teresa Ann Gilewski, MD, Protocol chair		Ph: 646-888-4557; 800-525-2225

Registry Information
Official Title		Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21
Trial Start Date		2001-03-13
Registered in ClinicalTrials.gov		NCT00030823
Date Submitted to PDQ		2001-12-26
Information Last Verified		2005-04-06
NCI Grant/Contract Number		CA05826, CA08748

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