Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Plasmodium Immunotherapy for Lung Cancer

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

Detailed description: This study is to be conducted in two stages. Stage 1 is the preliminary study, in which 20 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, changes in tumor-related parameters will be observed. Stage 2 is the primary study, in which 60 patients will be enrolled to receive vaccination with blood stage P. vivax to principally observe how well the patients tolerate Plasmodium infection and changes in tumor-related parameters.
  The duration of the planned treatment is 4-8 weeks, and successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last at least 28 days from the day of finding the Plasmodium from peripheral blood and will be terminated by DUO-COTECXIN or chloroquine phosphate plus primaquine phosphate.
  Each patient will be vaccinated with 5-10 mL of P. vivax-infected red blood cells containing approximately 1 × 10^8 Plasmodium parasites. After vaccination, the onset and duration of peripheral parasitemia and the infection rate will be observed. Once the infection rate reaches 0.1%, 10-30 mL of venous blood will be drawn, tested, and frozen to preserve the blood with parasitemia (to ensure that except for P. vivax, all other parameters meet the blood donation standards), which will be used to vaccinate subsequent patients.

Eligibility: Inclusion Criteria:
  -  18-65 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
  -  More than four weeks since the end of targeted therapy, or radiotherapy and chemotherapy (concurrent or sequential)
  -  After the initial radiotherapy and chemotherapy, the objective response time is ≤ 4 weeks, according to the RECIST criteria (i.e., poor efficacy of initial treatment)
  -  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 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
  -  Brain metastases
  -  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 splenectomy or splenomegaly
  -  Pregnant and nursing women
  -  Patients who have participated in other clinical studies during the previous three months
  -  Any condition that makes the subject ineligible to participate (in the opinion of the investigator)

Relevance to patient case: not relevant