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| Name | Class |
|---|---|
| National Health Research Institutes, Taiwan | OTHER |
The specific aims of this study are as follows:
In this trial, we will immunize metastatic colorectal cancer patients with recombinant CEA-pulsed DCs mixed with tetanus toxoid by subcutaneous injection. Low dose IL-2 will be given subcutaneously following DC vaccination to boost the growth of T cells. We will adapt "Simon's optimal two-stage design" for this study. In the first stage, we will treat 12 patients to evaluate the safety of this new protocol. If there are no severe toxicities/side effects and there is at least one patient that had stable disease or better clinical response, then we will proceed to the second stage and treat additional 25 patients. We will follow the clinical outcome of these 37 patients. The immune responses against CEA before and after vaccination will be examined.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEA pulsed dendritic cells | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the clinical responses of vaccinated patients 6 weeks after the first injection |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Lan Yu, R.N. | Contact | 011-886-23123456 | 7677 |
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Whang-Peng, M.D. | National Health Research Institutes, Taiwan | Principal Investigator |
| Hui-Ju Ch'ang, M.D. | National Health Research Institutes, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27558635 | Derived | Liu KJ, Chao TY, Chang JY, Cheng AL, Ch'ang HJ, Kao WY, Wu YC, Yu WL, Chung TR, Whang-Peng J. A phase I clinical study of immunotherapy for advanced colorectal cancers using carcinoembryonic antigen-pulsed dendritic cells mixed with tetanus toxoid and subsequent IL-2 treatment. J Biomed Sci. 2016 Aug 24;23(1):64. doi: 10.1186/s12929-016-0279-7. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Ann-Li Cheng, M.D. |
| National Taiwan University Hospital |
| Principal Investigator |
| Ko-Jiunn Liu, Ph.D. | National Health Research Institutes, Taiwan | Principal Investigator |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |