Clinical trial · Interventional
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21
NCT00470574CI-TRIAL-00048350completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| QS21 | Biological | — | UNRESOLVED |
| sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine Therapy and QS21
- description
- Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease. Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays. After completion of study treatment, patients are followed every 3 months
- interventionNames
- Biological: QS21
- Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine
- Other: immunoenzyme technique
- Other: immunologic technique
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Safety
- timeFrame
- 2 years
- measure
- Immune Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.