Status:
UNKNOWN
Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The specific aims of this study are as follows: 1. Primary endpoint: to evaluate the clinical responses of vaccinated patients. 2. Secondary endpoint: to evaluate the safety of this treatment and the...
Detailed Description
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00154713
Start Date
July 1 2005
End Date
July 1 2005
Last Update
September 12 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan