Clinical trial · Interventional
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma
- 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy. PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALVAC-CEA-B7.1 vaccine | Biological | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| tetanus toxoid | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic colorectal adenocarcinoma * No clinically active CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 6 months Hematopoietic: * Lymphocyte count at least 1,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * AST/ALT less than 3 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present) * No hepatocellular dysfunction * No cirrhosis Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No uncontrolled coronary artery disease * No symptomatic congestive heart failure Pulmonary: * No uncontrolled chronic obstructive lung disease Gastrointestinal: * No unsolved bowel obstruction or subobstruction * No uncontrolled Crohn's disease * No ulcerative colitis * No concurrent chronic diarrhea Immunologic: * HIV negative * No immunocompromised patients * No diagnosis of altered immune function, including: * Lupus erythematosus * Sjogren's syndrome * Scleroderma * Myasthenia gravis * Goodpasture's disease * Addison's disease * Hashimoto's thyroiditis * Active Graves' disease * No known allergy to egg products or neomycin * No prior adverse reaction to tetanus toxoid-containing vaccines Other: * No significant comorbid medical function * No uncontrolled infection * No unstable diabetes mellitus * No uncontrolled thyroid function abnormalities * No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix * No other medical illness or mental status that would preclude study participation * No prior severe toxicity to adjuvant chemotherapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior CEA-directed immunotherapy * No other concurrent immunotherapy Chemotherapy: * At least 6 months since prior adjuvant chemotherapy * No prior chemotherapy for metastatic disease * No other concurrent chemotherapy Endocrine therapy: * No concurrent daily use of systemic steroids * No concurrent nonsubstitutional hormonal therapy Radiotherapy: * No prior radiotherapy to more than 50% of all nodal groups * No concurrent radiotherapy except for palliative purposes involving less than 20% of bone marrow reserve Surgery: * No prior major organ allograft * Recovered from prior surgery Other: * At least 28 days since prior investigational products * No other concurrent investigational products
References
Publications (1)
- RESULTKaufman HL, Lenz HJ, Marshall J, Singh D, Garett C, Cripps C, Moore M, von Mehren M, Dalfen R, Heim WJ, Conry RM, Urba WJ, Benson AB 3rd, Yu M, Caterini J, Kim-Schulze S, Debenedette M, Salha D, Vogel T, Elias I, Berinstein NL. Combination chemotherapy and ALVAC-CEA/B7.1 vaccine in patients with metastatic colorectal cancer. Clin Cancer Res. 2008 Aug 1;14(15):4843-9. doi: 10.1158/1078-0432.CCR-08-0276. PMID 18676757