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| ID | Type | Description | Link |
|---|---|---|---|
| ONYVAX-SGCRO01 | |||
| NCI-V00-1599 |
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RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer.
OBJECTIVES:
OUTLINE: This is an open-label study. Patients are assigned to one of three treatment arms.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 45 patients (15 per treatment arm) will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG vaccine | Biological | |||
| monoclonal antibody 105AD7 anti-idiotype vaccine | Biological | |||
| alum adjuvant | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Fiona J. Lofts, MD | St. George's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. George's Hospital | London | England | SW17 0QT | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| D000536 | Aluminum Hydroxide |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
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