Impaired Immunity in Patients With Cancer: Influence of Cancer Stage, Chemotherapy, and Cytomegalovirus Infection

February 29, 2008 updated by: Mackay Memorial Hospital

Adjustment of Optimal Immune System by Using Cytokine Cocktails Before Applying DC Vaccine

According to a survey from Department of Health in 2004, cancer has been the leading cause of death in the Taiwan area. In 2004, people died of cancer, accounting for 27.2 percent of all deaths. The major reason of the superior grade is that cancer has the ability to escape the surveillance of immune system. It is also a main issue to address in medical research.

Dendritic cells (DCs), the most potent APC, are located at sites of pathogen entry, acquire antigens from pathogens or pathogen-infected cells, and process these antigens for both class I and class II presentation. Upon antigen encounter, they termed immature DCs, undergo a maturation process, they are capable to present captured antigens to T cells. This maturation step allows DC migration to trigger adaptive immune responses. These features make DCs very good candidates for therapy against various pathological conditions including malignancies.

Therefore, two concepts in this project will be concerned: one is enhancement of T cell immunity and the other is improvement of the efficiency of DC-tumor fusion. The strategy of enhance T cell is using well-known cytokines, such as IL2, and IL7 to expand the tumor-specific CD4 and CD8 T cells before DC-vaccine treatment. In the past, scientists utilized polyethyleneglycol to fuse cancer cells and dendritic cells. However, the results were devastating. Two new approaches of the DC vaccine will be applied to this study: DC-tumor fusion and DC phagocytosed apoptosed tumor cells. Whole tumor cells will be fused with DCs by combining hypotonic buffer and electrical-based fusion protocols. The safety of hybrid cell vaccination has been shown in clinical trials with some encouraging anti-tumour effects. However, data are as yet insufficient to assess a clear therapeutic benefit. Hopefully, the combination of two strategies will improve the efficiency of DC vaccine and boost survival of cancer patients.

As we have gained a clearer understanding of the cellular and molecular events that modulate antigen presentation and T cell activation in vivo, new strategies have emerged, allowing the development of more potent second generation DC vaccines.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 251
        • Recruiting
        • Mackay Memorial Hospital
        • Principal Investigator:
          • I-Hsuan A Chen, D.Phil

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For observational study: health volunteers and cancer patients
  • For DC vaccine: patients with solid tumor

Exclusion Criteria:

  • leukemia

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early (E)
Early stage cancer
Other: Immune profiling and DC vaccine
  1. For observational study (immune profiling): blood sampling 3-5 mL
  2. For DC vaccine: one dose of DC vaccine(~10 million cells)/2 week for at least 6 month or until progression.
Other Names:
  • cytokine cocktail
Other: Advanced (A)
Advanced stage cancer (Stage IV without treatment)
Other: Immune profiling and DC vaccine
  1. For observational study (immune profiling): blood sampling 3-5 mL
  2. For DC vaccine: one dose of DC vaccine(~10 million cells)/2 week for at least 6 month or until progression.
Other Names:
  • cytokine cocktail
Other: Terminal (T)
Terminal stage cancer (Stage IV with chemotherapy)
Other: Immune profiling and DC vaccine
  1. For observational study (immune profiling): blood sampling 3-5 mL
  2. For DC vaccine: one dose of DC vaccine(~10 million cells)/2 week for at least 6 month or until progression.
Other Names:
  • cytokine cocktail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune status
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: I-Hsuan A Chen, D.Phil, Mackay Memorial Hospital

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

October 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 3, 2008

Last Update Submitted That Met QC Criteria

February 29, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMH-I-S-321
  • MMH-I-S-401

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.

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