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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154713
First received: September 8, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
  Purpose

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

Condition Intervention Phase
Colorectal Cancer
Biological: CEA pulsed dendritic cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 37
Study Start Date: July 2005
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154713

Contacts
Contact: Wei-Lan Yu, R.N. 011-886-23123456 ext 7677

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Wei-Lan Yu, R.N.    011-886-2-23123456 ext 7677      
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154713     History of Changes
Other Study ID Numbers: 27MD02
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
colorectal cancer
dendritic cell
CEA
IL-2

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014