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Lung Cancer, Nonsmall CellPhase 1/2NCT02786589

Plasmodium Immunotherapy for Lung Cancer

A Phase 1/2 study testing Blood-stage infection of P. vivax in people with Lung Cancer, Nonsmall Cell, run by State Key Laboratory of Respiratory Disease at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung Cancer, Nonsmall Cell
What is being tested?
Blood-stage infection of P. vivax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Jun 2016to 30 Dec 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

Chengzhi Zhou, M.D. contact

0086-20-83062888

China1 site, 1 recruiting

  • The First Affiliated Hospital, Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Chengzhi Zhou, M.D., 0086-20-83062888

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Plasmodium Immunotherapy for Advanced Non-small Cell Lung Cancer

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.

Read the 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.

Being tested
Blood-stage infection of P. vivax
Keywords
Lung cancer Immunotherapy, Plasmodium vivax, Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood-stage infection of P. vivaxBiological

    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.

Study groups in NCT02786589
Study groupRoleWhat they receive
Blood-stage infection of P. vivaxExperimentalThis is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.
Receives: Biological: Blood-stage infection of P. vivax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (9)

  1. 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).

    Measured: 2 years

  2. 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).

    Measured: 2 years

  3. Tumor marker level

    The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.

    Measured: 2 years

  4. Objective response rate(ORR)

    The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.

    Measured: 2 years

  5. 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.

    Measured: 2 years

  6. Time to progression(TTP)

    The time starting from the research to tumor progression.

    Measured: 2 years

  7. 1 year of survival rate

    The number of cancer cases remaining after 1 year of treatment/the total number of cancer cases treated*100%.

    Measured: 2 years

  8. 2 year of survival rate

    The number of cancer cases remaining after 2 year of treatment/the total number of cancer cases treated*100%.

    Measured: 2 years

  9. Immunological index

    Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on) in peripheral blood by cytometry.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study start27 Jun 2016
  3. Primary completion1 Jul 2020
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786589
Sponsor's protocol ID
KLRD-L-001
Status last verified
Jun 2023
First submitted
26 May 2016
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21931708

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Blood-stage infection of P. vivax in people with Lung Cancer, Nonsmall Cell, run by State Key Laboratory of Respiratory Disease at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chengzhi Zhou, M.D. (0086-20-83062888), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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