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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
CEA pulsed dendritic cells
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, dendritic cell, CEA, IL-2

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Outcomes

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

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00154713
Brief Title
Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

5. Study Description

Brief Summary
The specific aims of this study are as follows: Primary endpoint: to evaluate the clinical responses of vaccinated patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, dendritic cell, CEA, IL-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
CEA pulsed dendritic cells
Primary Outcome Measure Information:
Title
evaluate the clinical responses of vaccinated patients 6 weeks after the first injection
Secondary Outcome Measure Information:
Title
evaluate the safety of this treatment and the immune responses against CEA before and after the treatment 6 weeks after the first injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Lan Yu, R.N.
Phone
011-886-23123456
Ext
7677
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Whang-Peng, M.D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui-Ju Ch'ang, M.D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Li Cheng, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ko-Jiunn Liu, Ph.D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Lan Yu, R.N.
Phone
011-886-2-23123456
Ext
7677

12. IPD Sharing Statement

Citations:
PubMed Identifier
27558635
Citation
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.
Results Reference
derived

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

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