N/A
N=14
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00030823 ↗Enrolled (actual)
14
Serious AEs
7.7%
Results posted
Dec 2015
Primary outcome: Primary: Safety — 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine (Biological); QS21 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
13 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00030823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.