Plasmodium Immunotherapy for Lung Cancer

NCT02786589 | Unknown Phase 1

• 1 other identifier: KLRD-L-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer, Nonsmall Cell

Keywords

Lung cancer Immunotherapy; Plasmodium vivax; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (9)

• Progression free survival(PFS)

  2 years

• Overall survival(OS)

  2 years

• Tumor marker level

  2 years

• Objective response rate(ORR)

  2 years

• Quality of life score

  2 years

Study Arms (1)

Blood-stage infection of P. vivax

EXPERIMENTAL

This is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.

Biological: Blood-stage infection of P. vivax

Interventions

Blood-stage infection of P. vivax BIOLOGICAL

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.

Blood-stage infection of P. vivax

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead
• CAS Lamvac Biotech Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 21931708 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Malaria, Vivax

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ming Ou-Yang, M.D.

  The First Affiliated Hospital, Guangzhou Medical University，China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengzhi Zhou, M.D.

CONTACT

0086-20-83062888

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: June 27, 2016
• Primary Completion: July 1, 2020
• Study Completion: December 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)