Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment - Article
Clinical Trial: Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment
This study is currently recruiting patients.
Verified by National Taiwan University Hospital July 2005
The specific aims of this study are as follows:
|Colorectal Cancer || Vaccine: CEA pulsed dendritic cells ||Phase I |
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Secondary Outcomes: evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection
Expected Total Enrollment: 37
Study start: July 2005; Expected completion: March 2008
Last follow-up: July 2005; Data entry closure: September 2007
- 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.
- 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
Location and Contact Information
National Taiwan University Hospital, Taipei, Taiwan; Recruiting
Jacqueline Whang-Peng, M.D., Principal Investigator, National Health Research Institutes
Hui-Ju Ch''''ang, M.D., Principal Investigator, National Health Research Institutes
Ann-Li Cheng, M.D., Principal Investigator, National Taiwan University Hospital
Ko-Jiunn Liu, Ph.D., Principal Investigator, National Health Research Institutes
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154713
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13