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

NCT ID: NCT00521287

Last Updated: 2008-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-12-31

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early (E)

Early stage cancer

Group Type: OTHER

Immune profiling and DC vaccine

Intervention Type: OTHER

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.

Advanced (A)

Advanced stage cancer (Stage IV without treatment)

Group Type: OTHER

Immune profiling and DC vaccine

Intervention Type: OTHER

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.

Terminal (T)

Terminal stage cancer (Stage IV with chemotherapy)

Group Type: OTHER

Immune profiling and DC vaccine

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

cytokine cocktail

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• leukemia

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mackay Memorial Hospital

Principal Investigators

I-Hsuan A Chen, D.Phil

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

I-Hsuan A Chen, D.Phil

Role: CONTACT

ihsuanch.b792@ms1.mmh.org.tw

+886228094661 ext. 2396

Yen-Ta Lu, MD. PhD

Role: CONTACT

ytlhl@ms2.mmh.org.tw

+886228094661 ext. 3063

Other Identifiers

MMH-I-S-401

Identifier Type: -

Identifier Source: secondary_id

MMH-I-S-321

Identifier Type: -

Identifier Source: org_study_id