Plasmodium Immunotherapy for Lung Cancer

Launched by STATE KEY LABORATORY OF RESPIRATORY DISEASE · May 26, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Plasmodium immunotherapy for patients with advanced non-small cell lung cancer. The goal is to see how safe and effective this treatment is over a period of 3 to 6 months. Participants will receive treatment following a controlled infection with a type of malaria parasite, which is thought to help stimulate the immune system to fight cancer. Once the therapy is complete, participants will be given medication to eliminate the infection.

To join the trial, participants need to be between 18 and 70 years old and have a specific type of lung cancer that cannot be surgically removed. They should not have received other cancer treatments recently and must be in generally good health. If someone decides to participate, they can expect regular check-ups and will be closely monitored throughout the study. It's important to note that women must have a negative pregnancy test and agree to use birth control during the trial. Overall, this study aims to explore a potentially promising new approach to treating lung cancer.

Gender

ALL

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)