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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00521287
Enrollment
150
Registered
2007-08-27
Start date
2006-10-31
Completion date
2009-12-31
Last updated
2008-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Immunologic Surveillance, Vaccination, Immunotherapy, Dendritic Cells

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.

Interventions

OTHERImmune 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.

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* leukemia

Design outcomes

Primary

MeasureTime frame
Immune status5 years

Secondary

MeasureTime frame
Tumor response6 months

Countries

Taiwan

Contacts

Primary ContactI-Hsuan A Chen, D.Phil
ihsuanch.b792@ms1.mmh.org.tw+886228094661
Backup ContactYen-Ta Lu, MD. PhD
ytlhl@ms2.mmh.org.tw+886228094661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026