Vaccine-Preventable Diseases and Specific Vaccines |
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Clinical Trial: Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
This study has been suspended.
Purpose
RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Breast Cancer Male Breast Cancer | Drug: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine Drug: QS21 Procedure: biological response modifier therapy Procedure: non-specific immune-modulator therapy Procedure: non-tumor cell derivative vaccine Procedure: vaccine therapy | Phase I |
MedlinePlus related topics: Breast Cancer; Male Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Pilot Study of Vaccination With a Heptavalent Antigen-Keyhole Limpet Hemocyanin Conjugate Plus QS21 in Patients at High Risk for Breast Cancer Recurrence
OBJECTIVES:
- 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.
- Determine the toxic effects of this regimen in these patients.
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.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
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/mm^3
- WBC at least 3,000/mm^3
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:
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
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
Location Information
Teresa Ann Gilewski, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: February 14, 2002
ClinicalTrials.gov Identifier: NCT00030823
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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