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

September 8, 2005 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Wei-Lan Yu, R.N.
          • Phone Number: 7677 011-886-2-23123456

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 8, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27MD02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe