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

This study is currently recruiting patients.
Verified by National Taiwan University Hospital July 2005

Sponsors and Collaborators: National Taiwan University Hospital
National Health Research Institutes, Taiwan
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00154713

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
 Vaccine: CEA pulsed dendritic cells
Phase I
Phase II

MedlinePlus related topics:  Colorectal Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: evaluate the clinical responses of vaccinated patients 6 weeks after the first injection
Secondary Outcomes: evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection
Expected Total Enrollment:  37

Study start: July 2005;  Expected completion: March 2008
Last follow-up: July 2005;  Data entry closure: September 2007

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   -   75 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00154713

Wei-Lan Yu, R.N.      011-886-23123456  Ext. 7677 

Taiwan
      National Taiwan University Hospital, Taipei,  Taiwan; Recruiting
Wei-Lan Yu, R.N.  011-886-2-23123456  Ext. 7677 

Study chairs or principal investigators

Jacqueline Whang-Peng, M.D.,  Principal Investigator,  National Health Research Institutes   
Hui-Ju Ch''''ang, M.D.,  Principal Investigator,  National Health Research Institutes   
Ann-Li Cheng, M.D.,  Principal Investigator,  National Taiwan University Hospital   
Ko-Jiunn Liu, Ph.D.,  Principal Investigator,  National Health Research Institutes   

More Information

Study ID Numbers:  27MD02
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00154713
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13

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