Status:
UNKNOWN
Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer
Lead Sponsor:
University College, London
Conditions:
Adenocarcinoma of Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the study is to evaluate the safety and anti-tumour activity of MSCTRAIL in addition to chemotherapy in metastatic Non-small cell lung cancer (NSCLC) patients in a Phase I/II clinical trial...
Detailed Description
Phase 1: A first-in-human, single-centre, accelerated, dose de-escalation design with a modified Bayesian continual reassessment method (mCRM) to estimate the recommended Phase II dose (RP2D) of MSCT...
Eligibility Criteria
Inclusion
- Inoperable stage IIIb/IV histologically/cytologically confirmed lung adenocarcinoma
- EGFR mutation and EML4-ALK translocation negative
- Patients with evaluable but unmeasurable disease can be included in the phase I study, but disease must be measurable (CT scan must be within 28 days of randomisation) to be included in the phase II study
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Age at least 18 years
- Adequate haematological status:
- Haemoglobin ≥100g/L
- Neutrophil count ≥1.5 x 109/L
- Platelets ≥100 x 109 /L
- Adequate organ function:
- Bilirubin ≤1.5 x ULN
- ALT or AST ≤3 x ULN (≤5 x ULN is acceptable with liver metastases)
- Creatinine clearance ≥ 60 ml/min (C\&G or EDTA)
- Negative pregnancy test for female patients of child bearing potential.
- Male subjects and women of child bearing potential must agree to use an acceptable method of birth control for the duration of the trial and for 12 months after the last trial treatment administration.
- Ability to understand and provide written informed consent
- Ability to comply with the requirements of the protocol
- Exclusion Criteria:
- Prior chemotherapy, hormonal therapy, radiotherapy (including palliative radiotherapy), immunotherapy or treatment with an investigational drug for advanced NSCLC.
- Any surgical procedure in the previous 6 weeks prior to registration/ randomisation
- Known respiratory failure with baseline resting SpO2 \<88%
- Long term oxygen therapy
- Severe intercurrent infection
- Active or infected wounds
- Yellow fever vaccination within 30 days prior to trial registration/randomisation
- Subject has known sensitivity to any of the trial drugs to be administered during the trial.
- Any contraindication to the administration and use of cisplatin, pemetrexed, vitamin B12 or folic acid
- Prior malignancy other than NSCLC (except if the tumour was a non-melanoma skin tumour that has been completely excised or in situ cervix carcinoma), unless have been treated with curative intent with no evidence of disease for \> 3 years
- Evidence of symptomatic brain metastases requiring treatment
- Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[New York Heart Association \> class II\]) within 1 year of enrolment
- Known inflammatory bowel disease
- Known hepatitis B or C infection, human immunodeficiency virus (HIV)-positive patients
- Pregnant women or those who are breast feeding
- Other medications, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, or may interfere with the interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial
Exclusion
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03298763
Start Date
March 5 2019
End Date
September 1 2025
Last Update
April 28 2021
Active Locations (1)
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1
University College London Hospital
London, United Kingdom