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

Mackay Memorial Hospital

Status and phase: Unknown; Phase 2

Conditions: Neoplasms

Treatments: Other: Immune profiling and DC vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00521287

MMH-I-S-401

MMH-I-S-321

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• leukemia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Early (E)

Other group

Description:

Early stage cancer

Treatment:

Other: Immune profiling and DC vaccine

Advanced (A)

Other group

Description:

Advanced stage cancer (Stage IV without treatment)

Treatment:

Other: Immune profiling and DC vaccine

Terminal (T)

Other group

Description:

Terminal stage cancer (Stage IV with chemotherapy)

Treatment:

Other: Immune profiling and DC vaccine