Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Sequential Phase II Study of the Anti-Idiotype Monoclonal Antibody Vaccine CeaVac and TriAb in Patients With Minimal Metastatic Colorectal Cancer
NCT00033748CI-TRIAL-00023138completedPhase 2ClinicalTrials.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 make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have colorectal cancer that has spread to the liver.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody 11D10 anti-idiotype | Biological | — | UNRESOLVED |
| monoclonal antibody 3H1 Alu Gel | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined Monoclonal Antibody Therapy
- description
- Patients with minimal metastatic colorectal cancer are treated with 2 anti-idiotype monoclonal antibodies
- interventionNames
- Biological: monoclonal antibody 11D10 anti-idiotype
- Biological: monoclonal antibody 3H1 Alu Gel
Primary outcomes (1)
- measure
- Recurrence free survival
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Toxicity
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed hepatic colorectal metastases * Must have undergone complete resection of hepatic colorectal metastases with tumor-free margins (curative resection) at least 6, but no more than 10, weeks prior to study entry * No evaluable or measurable disease after hepatic resection, documented by intraoperative palpation or imaging studies including intraoperative ultrasound, CT scan, or MRI * No hereditary non-polyposis colon cancer type B * No CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * CTC 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin no greater than 2 mg/dL * AST no greater than 2 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN Gastrointestinal: * No celiac disease * No familial polyposis * No Gardner's syndrome * No Peutz-Jeghers syndrome Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No seizure disorders requiring continuous medication * No history of clinically significant hypersensitivity reactions, including known hypersensitivity to rodent proteins * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine antibodies (e.g., oncoscint scan) * No prior monoclonal antibody 3H1 anti-idiotype vaccine or monoclonal antibody 11D10 anti-idiotype vaccine Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * Prior treatment for primary lesion or hepatic metastases allowed * No concurrent immunomodulatory therapy
References
Publications (1)
- RESULTPosner MC, Niedzwiecki D, Venook AP, Hollis DR, Kindler HL, Martin EW, Schilsky RL, Goldberg RM, Mayer RJ. A phase II prospective multi-institutional trial of adjuvant active specific immunotherapy following curative resection of colorectal cancer hepatic metastases: cancer and leukemia group B study 89903. Ann Surg Oncol. 2008 Jan;15(1):158-64. doi: 10.1245/s10434-007-9654-7. Epub 2007 Nov 16. PMID 18008108