Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00030823
First received: February 14, 2002
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer.
PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine Biological: QS21 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21 |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence.
Secondary Outcome Measures:
- Determine the toxic effects of this regimen in these patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | March 2001 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaccine
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.
|
Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine Biological: QS21 |
Detailed Description:
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030823
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:
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.
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00030823 History of Changes |
| Other Study ID Numbers: | 01-019, MSKCC-01019, NCI-H01-0084 |
| Study First Received: | February 14, 2002 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 stage IIIC breast cancer male breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic |
Keyhole-limpet hemocyanin QS 21 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013