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

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00521287
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
38
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Immune profiling and DC vaccine
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Adjustment of Optimal Immune System by Using Cytokine Cocktails Before Applying DC Vaccine
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Anticipated Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: Early (E)

Early stage cancer

Other: Immune profiling and DC vaccine
For observational study (immune profiling): blood sampling 3-5 mL 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
    For observational study (immune profiling): blood sampling 3-5 mL 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
    For observational study (immune profiling): blood sampling 3-5 mL 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Immune status [5 years]

    Secondary Outcome Measures

    1. Tumor response [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • For observational study: health volunteers and cancer patients

    • For DC vaccine: patients with solid tumor

    Exclusion Criteria:
    • leukemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mackay Memorial Hospital Taipei Taiwan 251

    Sponsors and Collaborators

    • Mackay Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00521287
    Other Study ID Numbers:
    • MMH-I-S-321
    • MMH-I-S-401
    First Posted:
    Aug 27, 2007
    Last Update Posted:
    Mar 3, 2008
    Last Verified:
    Aug 1, 2007
    Keywords provided by , ,
    Immunologic Surveillance
    Vaccination
    Immunotherapy
    Dendritic Cells

    Study Results

    No Results Posted as of Mar 3, 2008