N/A
Completed N=7
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00470574 ↗Enrolled (actual)
7
Serious AEs
42.9%
Results posted
Nov 2020
Primary outcomePrimary: Safety
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.
PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
— | — |
| PRIMARY Immune Response |
— | — |
| SECONDARY Presence of Circulating Tumor Cells |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00470574). 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. Informational only — not medical advice.