Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Taiwan University Hospital
Collaborator:
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154713
First received: September 8, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
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Purpose
The specific aims of this study are as follows:
- Primary endpoint: to evaluate the clinical responses of vaccinated patients.
- Secondary endpoint: to evaluate the safety of this treatment and the immune responses against CEA before and after the treatment
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Biological: CEA pulsed dendritic cells |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Clinical Study of Immunotherapy for Advanced Colorectal Cancers Using CEA-Pulsed Dendritic Cells Mixed With Tetanus Toxoid and Subsequent IL-2 Treatment |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- evaluate the clinical responses of vaccinated patients 6 weeks after the first injection
Secondary Outcome Measures:
- evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection
| Estimated Enrollment: | 37 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have metastatic colorectal cancer.
- Patients must have at least one measurable lesion.
- Patients’serum level of CEA must be higher than 5 times of the normal value
- Patients’disease must have failed chemotherapy with 5FU, CPT-11 or oxaliplatin.
- Patients who are unsuitable or refuse chemotherapy will be considered eligible for this trial.
- Patients’age must be 20 or greater.
- Patients’estimated life expectancy is more than 3 months.
- Patients must have adequate bone marrow function, defined as WBC >= 3500/mm3, neutrophil >= 1500/mm3, lymphocyte >= 1,000/mm3, and platelet >= 100,000/mm3.
- Patients must have adequate liver and renal function, defined as serum alanine transaminase (ALT) and aspartate transaminase (AST) =< 5 times normal, bilirubin =< 1.5 times normal range, and creatinine =< 2 times upper normal limit.
- All patients should have documentation of negative result of penicillin test.
- Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Exclusion Criteria:
- Patients who have central nervous system metastasis except for those whose CNS disease has been treated with radiotherapy and/or surgery and has been stable for at least two weeks
- Patients who have active acute or chronic infection (at the discretion of the investigator).
- Pregnant or breast-nursing women
- Patients who have active cardiac disease requiring therapy for failure, angina, arrythmia, or infarction within the preceding 6 months (exception: any patient whose cardiac failure is compensated on medications)
- Patients who have asthma
- Patients who have autoimmune disease such as inflammatory bowel disease, lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis
- Patients who have serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Patients who have other prior or concurrent malignancy except for in-situ-carcinoma of cervix or adequately treated basal cell carcinoma of skin.
- Patients who received chemotherapy, steroid or biologic treatment within 4 weeks prior to enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154713
Contacts
| Contact: Wei-Lan Yu, R.N. | 011-886-23123456 ext 7677 |
Locations
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Wei-Lan Yu, R.N. 011-886-2-23123456 ext 7677 | |
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
| Principal Investigator: | 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: | Ann-Li Cheng, M.D. | National Taiwan University Hospital |
| Principal Investigator: | Ko-Jiunn Liu, Ph.D. | National Health Research Institutes, Taiwan |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00154713 History of Changes |
| Other Study ID Numbers: | 27MD02 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
colorectal cancer dendritic cell CEA IL-2 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013