Plasmodium Immunotherapy for Lung Cancer
Primary Purpose
Lung Cancer, Nonsmall Cell
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Blood-stage infection of P. vivax
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer, Nonsmall Cell focused on measuring Lung cancer Immunotherapy, Plasmodium vivax, Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- 18-70 years of age, male or female
- Unresectable stage III or IV non-small cell lung cancer, diagnosed by histological and radiological findings (UICC, Seventh Ed.), and of any histological subtype. Cancer staging during the initial diagnosis must be confirmed by radiographic findings (CT and/or MRI and/or PET-CT)
- During study treatment, the patient should not receive other treatments, including chemotherapy, radiotherapy, targeted therapy, other biological therapy, physical therapy, traditional Chinese medicine, and so on
- At least 5 half-life of the targeted drug (the half- life calculation is based on the targeted drug instructions) since the end the targeted therapy;More than 12 weeks since the end of radiotherapy or chemotherapy (common or continuous)
- Expected survival > 16 weeks
- ECGO score of 0 or 1
- PLT ≥100 × 10^9/L, WBC ≥ 4 × 10^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.)
- The patient's peripheral blood immune cell count and immune function test are close to normal or normal, and the heart and lungs and kidneys are normal.
- The patient is willing to receive Plasmodium immunotherapy and is able to sign the informed consent
- For female patients: the result of a pregnancy test must be negative at screening. All subjects must consent to use birth control methods during treatment and for two months after discharge
- The subject is willing to follow the in-hospital exam and treatment and follow-up schedule
- The patient can return for regular scheduled follow-up visits during the 2-year follow-up period
- The subject agrees that the investigators may report and publish the results of this clinical study
Exclusion Criteria:
- Total ≤ 4 weeks after surgical treatment or other forms of treatments
- Active chronic lung diseases (hypoxemia due to bronchial asthma, tuberculosis, other conditions); lung metastatic tumor; other comorbid tumors
- Patients with newly diagnosed brain metastasis (not including the previous brain metastatic lesion, which is not visible by image at the time of screening)
- Patients with autoimmune disease or other immunodeficiency diseases
- Patients taking long-term steroids or immunosuppressants
- Patients with severe hemoglobin disease or severe G6PD deficiency
- Patients with active or chronic symptomatic hepatitis
- Liver impairment: ALT > 2.5 x ULN, AST > 2.5 x ULN, bilirubin > 1.5 x ULN
- Renal impairment: serum creatinine ≥ 1.5 x ULN
- Patients with chronic heart disease, primarily those with recent (within a year) myocardial infarction, serious arrhythmias, heart failure, or aortic aneurysm
- Patients with serious drug allergy
- Patients with splenectomy or splenomegaly
- Pregnant and nursing women
- Patients who participating in other clinical trials at the same time or less than 12 weeks since withdraw from other clinical trials
- Any condition that makes the subject ineligible to participate (in the opinion of the investigator)
Sites / Locations
- The First Affiliated Hospital, Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood-stage infection of P. vivax
Arm Description
This is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
Secondary Outcome Measures
Progression free survival(PFS)
Progression free survival(PFS):Starting from treatment until the disease is first found or the time of any cause of death(disease progression refers to tumor growth, or metastasis of primary tumor, or discovery of new lesions).
Overall survival(OS)
The time starting from the treatment to death of whatever causes (when subjects have lost to follow-up before death , the last follow-up time will be calculated as the time of death).
Tumor marker level
The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
Objective response rate(ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Quality of life score
Patients are regularly with QLQ-C30(cancer patient quality of life scale)to assess the quality of life of the patients.
Time to progression(TTP)
The time starting from the research to tumor progression.
1 year of survival rate
The number of cancer cases remaining after 1 year of treatment/the total number of cancer cases treated*100%.
2 year of survival rate
The number of cancer cases remaining after 2 year of treatment/the total number of cancer cases treated*100%.
Immunological index
Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on) in peripheral blood by cytometry.
Full Information
NCT ID
NCT02786589
First Posted
May 26, 2016
Last Updated
June 19, 2023
Sponsor
State Key Laboratory of Respiratory Disease
Collaborators
CAS Lamvac Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02786589
Brief Title
Plasmodium Immunotherapy for Lung Cancer
Official Title
Clinical Study of Plasmodium Immunotherapy for Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Key Laboratory of Respiratory Disease
Collaborators
CAS Lamvac Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and the effectiveness of Plasmodium immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung cancer.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.
Detailed Description
In our study,30 patients with stage III/IV NSCLC will be enrolled to receive vaccination with an optimal concentration and amount of blood-stage P. vivax to observe the infection time, rate and cycle; principal clinical symptoms such as fever and anemia; heart, liver and kidney function; changes in spleen morphology and function, and dynamic changes in the function of peripheral immune cells. Moreover, the patient's tolerance to Plasmodium infection and changes in tumor-related parameters will be observed.
The duration of the planned treatment is 3-6 months, and successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection. Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10^7 Plasmodium parasites. After vaccination, the onset and duration of peripheral parasitemia and the infection rate; principal clinical symptoms such as Chills, fever, pain (headache, joint pain, etc.), digestive tract reaction;peripheral hemogram changes;heart, liver and kidney function; changes in lung function, and dynamic changes in the function of peripheral immune cells will be observed. Moreover, the patient's tolerance to Plasmodium infection and changes in tumor-related parameters will be observed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nonsmall Cell
Keywords
Lung cancer Immunotherapy, Plasmodium vivax, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood-stage infection of P. vivax
Arm Type
Experimental
Arm Description
This is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.
Intervention Type
Biological
Intervention Name(s)
Blood-stage infection of P. vivax
Intervention Description
Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10^7 Plasmodium parasites.And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples.The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0
Description
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
Progression free survival(PFS):Starting from treatment until the disease is first found or the time of any cause of death(disease progression refers to tumor growth, or metastasis of primary tumor, or discovery of new lesions).
Time Frame
2 years
Title
Overall survival(OS)
Description
The time starting from the treatment to death of whatever causes (when subjects have lost to follow-up before death , the last follow-up time will be calculated as the time of death).
Time Frame
2 years
Title
Tumor marker level
Description
The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
Time Frame
2 years
Title
Objective response rate(ORR)
Description
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Time Frame
2 years
Title
Quality of life score
Description
Patients are regularly with QLQ-C30(cancer patient quality of life scale)to assess the quality of life of the patients.
Time Frame
2 years
Title
Time to progression(TTP)
Description
The time starting from the research to tumor progression.
Time Frame
2 years
Title
1 year of survival rate
Description
The number of cancer cases remaining after 1 year of treatment/the total number of cancer cases treated*100%.
Time Frame
2 years
Title
2 year of survival rate
Description
The number of cancer cases remaining after 2 year of treatment/the total number of cancer cases treated*100%.
Time Frame
2 years
Title
Immunological index
Description
Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on) in peripheral blood by cytometry.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years of age, male or female
Unresectable stage III or IV non-small cell lung cancer, diagnosed by histological and radiological findings (UICC, Seventh Ed.), and of any histological subtype. Cancer staging during the initial diagnosis must be confirmed by radiographic findings (CT and/or MRI and/or PET-CT)
During study treatment, the patient should not receive other treatments, including chemotherapy, radiotherapy, targeted therapy, other biological therapy, physical therapy, traditional Chinese medicine, and so on
At least 5 half-life of the targeted drug (the half- life calculation is based on the targeted drug instructions) since the end the targeted therapy;More than 12 weeks since the end of radiotherapy or chemotherapy (common or continuous)
Expected survival > 16 weeks
ECGO score of 0 or 1
PLT ≥100 × 10^9/L, WBC ≥ 4 × 10^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.)
The patient's peripheral blood immune cell count and immune function test are close to normal or normal, and the heart and lungs and kidneys are normal.
The patient is willing to receive Plasmodium immunotherapy and is able to sign the informed consent
For female patients: the result of a pregnancy test must be negative at screening. All subjects must consent to use birth control methods during treatment and for two months after discharge
The subject is willing to follow the in-hospital exam and treatment and follow-up schedule
The patient can return for regular scheduled follow-up visits during the 2-year follow-up period
The subject agrees that the investigators may report and publish the results of this clinical study
Exclusion Criteria:
Total ≤ 4 weeks after surgical treatment or other forms of treatments
Active chronic lung diseases (hypoxemia due to bronchial asthma, tuberculosis, other conditions); lung metastatic tumor; other comorbid tumors
Patients with newly diagnosed brain metastasis (not including the previous brain metastatic lesion, which is not visible by image at the time of screening)
Patients with autoimmune disease or other immunodeficiency diseases
Patients taking long-term steroids or immunosuppressants
Patients with severe hemoglobin disease or severe G6PD deficiency
Patients with active or chronic symptomatic hepatitis
Patients with other serious complications such as severe hemoptysis and massive pleural and ascitic fluid
Liver impairment: ALT > 2.5 x ULN, AST > 2.5 x ULN, bilirubin > 1.5 x ULN
Renal impairment: serum creatinine ≥ 1.5 x ULN
Patients with chronic heart disease, primarily those with recent (within a year) myocardial infarction, serious arrhythmias, heart failure, or aortic aneurysm
Patients with serious drug allergy
Patients with splenectomy or splenomegaly
Pregnant and nursing women
Patients who participating in other clinical trials at the same time or less than 12 weeks since withdraw from other clinical trials
Any condition that makes the subject ineligible to participate (in the opinion of the investigator)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengzhi Zhou, M.D.
Phone
0086-20-83062888
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Ou-Yang, M.D.
Organizational Affiliation
The First Affiliated Hospital, Guangzhou Medical University,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengzhi Zhou, M.D.
Phone
0086-20-83062888
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21931708
Citation
Chen L, He Z, Qin L, Li Q, Shi X, Zhao S, Chen L, Zhong N, Chen X. Antitumor effect of malaria parasite infection in a murine Lewis lung cancer model through induction of innate and adaptive immunity. PLoS One. 2011;6(9):e24407. doi: 10.1371/journal.pone.0024407. Epub 2011 Sep 9.
Results Reference
result
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Plasmodium Immunotherapy for Lung Cancer
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