Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00154713

Collaborator

National Health Research Institutes, Taiwan (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Biological: CEA pulsed dendritic cells	Phase 1/Phase 2

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 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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2005

Study Completion Date :

Jul 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

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