Abstract | PURPOSE: EXPERIMENTAL DESIGN: RESULTS: One hundred eighteen patients were randomized to receive either ALVAC before and concomitantly with chemotherapy (n = 39), ALVAC with tetanus adjuvant before and concomitantly with chemotherapy (n = 40), or chemotherapy followed by ALVAC (n = 39). Serious adverse events were largely gastrointestinal ( n = 30) and hematologic (n = 24). Overall, 42 patients (40.4%) showed objective clinical responses. All patients developed antibody responses against ALVAC, but increased anti-CEA antibody titers were detected in only three patients. Increases in CEA-specific T cells were detected in 50%, 37%, and 30% of patients in groups 1, 2, and 3, respectively. There were no differences in clinical or immune responses between the treatment groups. CONCLUSION: The combination of ALVAC-CEA/B7.1 vaccine and systemic chemotherapy has an acceptable safety profile in patients with metastatic colorectal cancer. Systemic chemotherapy did not affect the generation of CEA-specific T-cell responses following vaccination.
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Authors | Howard L Kaufman, Heinz-Josef Lenz, John Marshall, Deepti Singh, Chris Garett, Christine Cripps, Malcolm Moore, Margaret von Mehren, Richard Dalfen, William J Heim, Robert M Conry, Walter J Urba, Al B Benson 3rd, Maria Yu, Judy Caterini, Seunghee Kim-Schulze, Mark Debenedette, Danielle Salha, Thorsten Vogel, Ileana Elias, Neil L Berinstein |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 14
Issue 15
Pg. 4843-9
(Aug 01 2008)
ISSN: 1078-0432 [Print] United States |
PMID | 18676757
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- ALVAC vaccine
- B7-1 Antigen
- Carcinoembryonic Antigen
- Viral Vaccines
- Irinotecan
- Leucovorin
- Fluorouracil
- Camptothecin
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Topics |
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- B7-1 Antigen
(chemistry)
- Camptothecin
(administration & dosage, analogs & derivatives)
- Carcinoembryonic Antigen
(chemistry)
- Colorectal Neoplasms
(therapy)
- Female
- Fluorouracil
(administration & dosage)
- Humans
- Irinotecan
- Leucovorin
(administration & dosage)
- Male
- Middle Aged
- Neoplasm Metastasis
- T-Lymphocytes
(metabolism)
- Treatment Outcome
- Viral Vaccines
(therapeutic use)
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