Status:
COMPLETED
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells. ...
Detailed Description
OBJECTIVES: Primary * Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer. * Determine the IgG and Ig...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
- No evidence of disease
- Stable disease on hormonal therapy
- Stable disease must be present for ≥ 2 months and include \< 30% decrease or \< 20% increase in the sum of the longest diameter of target lesion
- No new target lesions or unequivocal progression of non-target lesions
- Elevation in the CA 153 (BR2729) or CEA values allowed
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female or male
- Menopausal status not specified
- Karnofsky performance status 80-100%
- Lymphocyte count ≥ 500/mm³
- WBC ≥ 3,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy to seafood
- No NYHA class III-IV cardiac disease
- No other active cancers except basal cell or squamous cell carcinoma of the skin
- No active infection requiring antibiotic treatment
- No known history of immunodeficiency or autoimmune disease
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior radiotherapy
- At least 4 weeks since prior surgery
- At least 6 weeks since prior immunotherapy
- No prior sialyl Lewisª antigen
- No concurrent immunosuppressive medications (i.e., corticosteroids)
- Concurrent hormonal therapy allowed
Exclusion
Key Trial Info
Start Date :
March 20 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00470574
Start Date
March 20 2007
End Date
January 24 2020
Last Update
November 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065