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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-01019 | |||
| NCI-H01-0084 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine | Biological |
| ||
| QS21 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0. | 2 years |
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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
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
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:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Ann Gilewski, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety | By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0. | All 13 participants experienced toxicities. | Posted | Number | participants | 2 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SGPT (ALT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTC-2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Teresa Gilewski | Memorial Sloan Kettering Cancer Center | 646-888-4557 | gilewskt@mskcc.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C078785 | saponin QA-21V1 |
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| Biological |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 1 |
| 13 |
| 13 |
| 13 |
| Derm, skin other | Skin and subcutaneous tissue disorders | CTC-2.0 | Systematic Assessment |
|
| Dyspepsia/heartburn | Gastrointestinal disorders | CTC-2.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTC-2.0 | Systematic Assessment |
|
| Fever | General disorders | CTC-2.0 | Systematic Assessment |
|
| Headache | General disorders | CTC-2.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Injection site reaction | Infections and infestations | CTC-2.0 | Systematic Assessment |
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| Leukocytes | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | CTC-2.0 | Systematic Assessment |
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| Pain, other | General disorders | CTC-2.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTC-2.0 | Systematic Assessment |
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| Rigors, chills | General disorders | CTC-2.0 | Systematic Assessment |
|
| SGOT (AST) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
| SGPT (ALT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |