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

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ClinicalTrials.gov Identifier: NCT00521287
Recruitment Status : Unknown
Verified August 2007 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 27, 2007
Last Update Posted : March 3, 2008
Sponsor:
Information provided by:

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
Neoplasms Other: Immune profiling and DC vaccine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2006
Primary Completion Date : September 2007
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: cytokine cocktail
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 Name: cytokine cocktail
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 Name: cytokine cocktail


Outcome Measures

Primary Outcome Measures :
  1. Immune status [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Tumor response [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • leukemia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521287


Contacts
Contact: I-Hsuan A Chen, D.Phil +886228094661 ext 2396 ihsuanch.b792@ms1.mmh.org.tw
Contact: Yen-Ta Lu, MD. PhD +886228094661 ext 3063 ytlhl@ms2.mmh.org.tw

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 251
Principal Investigator: I-Hsuan A Chen, D.Phil         
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: I-Hsuan A Chen, D.Phil Mackay Memorial Hospital
More Information

Responsible Party: Yen Ta Lu/ Dr., Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT00521287     History of Changes
Other Study ID Numbers: MMH-I-S-321
MMH-I-S-401
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: August 2007

Keywords provided by Mackay Memorial Hospital:
Immunologic Surveillance
Vaccination
Immunotherapy
Dendritic Cells

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs