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

NCT ID: NCT00154713

Last Updated: 2005-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2005-07-31

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 immune responses against CEA before and after the treatment

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; dendritic cell; CEA; IL-2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CEA pulsed dendritic cells

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jacqueline Whang-Peng, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Hui-Ju Ch'ang, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Ann-Li Cheng, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Ko-Jiunn Liu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wei-Lan Yu, R.N.

Role: CONTACT

Phone: 011-886-23123456

Facility Contacts

Wei-Lan Yu, R.N.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 27558635 (View on PubMed)

Other Identifiers

27MD02

Identifier Type: -

Identifier Source: org_study_id