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Colorectal CancerPhase 1/2NCT00154713

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

A Phase 1/2 study testing CEA pulsed dendritic cells in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
CEA pulsed dendritic cells
How many people
37 participants
Where
1 siteTaiwan
Study dates
Jul 2005to Jul 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Wei-Lan Yu, R.N. contact

011-886-23123456 ext. 7677

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei

    Wei-Lan Yu, R.N., 011-886-2-23123456 ext. 7677

    Recruiting

Other trials in Taiwan

About this 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

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
Read the 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.

Being tested
CEA pulsed dendritic cells
Keywords
colorectal cancer, dendritic cell, CEA, IL-2
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEA pulsed dendritic cellsBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00154713
Sponsor's protocol ID
27MD02
Status last verified
Jul 2005
First submitted
8 Sep 2005
Last updated
12 Sep 2005
Results posted
No

Publications

  • 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.

    PubMed 27558635

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CEA pulsed dendritic cells in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei-Lan Yu, R.N. (011-886-23123456 ext. 7677), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluate the clinical responses of vaccinated patients 6 weeks after the first injection. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00154713, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.

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