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

NCT00154713 | Unknown Phase 1

• 1 other identifier: 27MD02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are as follows:

1. 1.Primary endpoint: to evaluate the clinical responses of vaccinated patients.
2. 2.Secondary endpoint: to evaluate the safety of this treatment and the immune responses against CEA before and after the treatment

Conditions

Colorectal Cancer

Keywords

colorectal cancer; dendritic cell; CEA; IL-2

Outcome Measures

Primary Outcomes (1)

• evaluate the clinical responses of vaccinated patients 6 weeks after the first injection

Secondary Outcomes (1)

• evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection

Interventions

CEA pulsed dendritic cells BIOLOGICAL

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 27558635 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Lan Yu, R.N.

CONTACT

011-886-23123456

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: September 12, 2005

Record last verified: 2005-07

Locations

TW (1)