Safety and Efficacy of Mix Vaccine in Lung Carcinoma Patient

NCT ID: NCT02333474

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

Brief Summary

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

Detailed Description

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line Version 2.2014.

Group Type: ACTIVE_COMPARATOR

standard treatment

Intervention Type: OTHER

Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

MV+control

Patients in this group will be receiving both standard therapy according to NCCN guide line Version 2.2014 and simultaneous injection of mix vaccine (MV). MV will be given

Group Type: EXPERIMENTAL

MV mix vaccine

Intervention Type: BIOLOGICAL

MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), BCG (Bacille Calmette-Guerin vaccine), measles, Serratia and pneumococcus. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.

standard treatment

Intervention Type: OTHER

Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

Interventions

MV mix vaccine

MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), BCG (Bacille Calmette-Guerin vaccine), measles, Serratia and pneumococcus. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.

Intervention Type: BIOLOGICAL

standard treatment

Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

Intervention Type: OTHER

Other Intervention Names

MV

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with lung carcinoma based on histology

2. Evaluable lesions on imaging study

3. Without known immunodeficiency

4. Age >18 and <80 years ago

Exclusion Criteria

1. Patients is unable or unwilling to sign informed consent

2. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication

3. Positive HIV and/or RPR (rapid plasma reagin )

4. Female patient who is pregnant or breast feeding

5. Patients, based on the opinion pf the investigator, should not be enrolled into this study

6. Prior anti-cancer vaccine or biological immunotherapy

7. Allergic to any known ingredient of the MV compound

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kecheng Xu, MD

Role: STUDY_CHAIR

Fuda Cancer Hospital

Locations

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Countries

China

Related Links

http://www.fudahospital.com/

related information

Other Identifiers

FudaCH

Identifier Type: -

Identifier Source: org_study_id