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Plasmodium Immunotherapy for Lung Cancer

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ClinicalTrials.gov Identifier: NCT02786589
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
CAS Lamvac Biotech Co., Ltd.
Information provided by (Responsible Party):
Ming Ou-Yang, State Key Laboratory of Respiratory Disease

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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Nonsmall Cell Biological: Blood-stage infection of P. vivax Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Plasmodium Immunotherapy for Advanced Non-small Cell Lung Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Malaria

Arm Intervention/treatment
Experimental: Blood-stage infection of P. vivax
This is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.
Biological: Blood-stage infection of P. vivax
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 Measures :
  1. Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0 [ Time Frame: 2 years ]
    Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.


Secondary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: 2 years ]
    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).

  2. Overall survival(OS) [ Time Frame: 2 years ]
    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).

  3. Tumor marker level [ Time Frame: 2 years ]
    The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.

  4. Objective response rate(ORR) [ Time Frame: 2 years ]
    The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.

  5. Quality of life [ Time Frame: 2 years ]
    Patients are regularly with QLQ-C30(cancer patient quality of life scale)to assess the quality of life of the patients.

  6. Time to progression(TTP) [ Time Frame: 2 years ]
    The time starting from the research to tumor progression.

  7. 1 year of survival rate [ Time Frame: 2 years ]
    The number of cancer cases remaining after 1 year of treatment/the total number of cancer cases treated*100%.

  8. 2 year of survival rate [ Time Frame: 2 years ]
    The number of cancer cases remaining after 2 year of treatment/the total number of cancer cases treated*100%.

  9. Immunological index [ Time Frame: 2 years ]
    Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on) in peripheral blood by cytometry.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786589


Contacts
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Contact: Chengzhi Zhou, M.D. 0086-20-83062888

Locations
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China, Guangdong
The First Affiliated Hospital, Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Chengzhi Zhou, M.D.    0086-20-83062888      
Sponsors and Collaborators
State Key Laboratory of Respiratory Disease
CAS Lamvac Biotech Co., Ltd.
Investigators
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Principal Investigator: Ming Ou-Yang, M.D. The First Affiliated Hospital, Guangzhou Medical University,China

Publications of Results:
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Responsible Party: Ming Ou-Yang, Associate Chief Physician, State Key Laboratory of Respiratory Disease
ClinicalTrials.gov Identifier: NCT02786589     History of Changes
Other Study ID Numbers: KLRD-L-001
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Ou-Yang, State Key Laboratory of Respiratory Disease:
Lung cancer Immunotherapy
Plasmodium vivax
Immunotherapy

Additional relevant MeSH terms:
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Lung Neoplasms
Malaria
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Protozoan Infections
Parasitic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs