None listed
Conditions
Brief summary
Mesothelioma is an aggressive cancer with limited treatment options. We have conducted studies of a specific extract from Leptospermum petersonii (QV0; lemon scent tea tree) which showed reduction of cancer activities in the petri dish and also reduction of tumour in mice studies. This project is a first-in-human study of Leptospermum petersonii extract. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with mesothelioma. Study details All participants will be provided with Leptospermum petersonii extract to take by mouth for 6 weeks. Every 6 weeks, the dose of extract will be increased for 24 weeks. During this time, participants will be asked to provide blood, stool and urine samples, complete questionnaires, and will be monitored for side effects. It is hoped that this study will help determine if Leptospermum petersonii extract can be used safely in humans to control cancer by itself or in combination with other conventional treatment in mesothelioma patients
Interventions
Test drug: QV0 containing leptospermum petersonii extract
- the dose administered, level 1: 150mg per day; level 2: 300mg per day; level 3: 600mg per day; level 4: 1200mg per day. e.g. First 5 participants receive level 1 and once their 6 weeks of treatment are completed the next 5 participants complete level 2, etc.
- the duration of administration, oral QV0 capsules daily every 3 weeks (one cycle) for 6 weeks
- the mode of administration, oral capsule. laboratory test will be used to monitor a
Test drug: QV0 containing leptospermum petersonii extract - the dose administered, level 1: 150mg per day; level 2: 300mg per day; level 3: 600mg per day; level 4: 1200mg per day. e.g. First 5 participants receive level 1 and once their 6 weeks of treatment are completed the next 5 participants complete level 2, etc. - the duration of administration, oral QV0 capsules daily every 3 weeks (one cycle) for 6 weeks - the mode of administration, oral capsule. laboratory test will be used to monitor adherence to the intervention.
Sponsors
ADDRI
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria must be met at the time of study screening. • Histological or cytological documentation of mesothelioma • Radiological progression following treatment with standard lines of therapy OR if a patient is not a candidate for standard therapy or does not wish to have standard therapy in the dose escalation phase OR Patients suitable for standard of care chemotherapy-based therapy or immunotherapy treatment in the dose expansion phase • Patient must have at least one measurable lesion according to the RECIST criteria version 1.1 for peritoneal mesothelioma and modified RECIST criteria for pleural mesothelioma • Male or female patients, 18 years of age. • Eastern Cooperative Oncology Group (ECOG) performance status of 2. • Life expectancy of at least 3 months. • Women of childbearing potential (age 18 – 55 years old) and men must agree to use adequate contraception from the time of signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. • Adequate bone marrow, liver and renal function as assessed by the following laboratory testing conducted within 14 days of starting to study treatment: o Total bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) o Alanine transaminase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN o Serum creatinine less than or equal to 1.5 x ULN or Glomerular filtration rate (GFR) greater than or equal to 60 ml/min/m2 o INR/PTT less than or equal to 1.5 x ULN (patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. o Platelet count greater than or equal to 100 x 109/L o Haemoglobin (Hb) greater than or equal to 90g/L o Absolute Neutrophil count (ANC) greater than or equal to 1.5 x 109/L • Sufficient archival tissue at screening (paraffin block or at least 15 slides)
Exclusion criteria
• Previous or concurrent cancer that is distinct in primary site or histology from mesothelioma within 3 years from the date of screening EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumours (Ta, Tis and T1). • Herbal supplements (such as St John’s Wort), nutritional supplements with 10 day washout period • Major surgical procedures in the last four weeks. • Pregnancy or breast-feeding. • Congestive heart failure, New York Heart Association (NYHA) class 2. • Unstable angina (angina at rest) or new-onset angina ( 3 months). Myocardial infarction less than 6 months before eligibility screening. • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted). • Uncontrolled hypertension (Systolic blood pressure > 150 mmHg or diastolic pressure > 90 mm Hg despite optimal medical management). • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including Transient Ischemic Attacks), deep vein thrombosis or pulmonary embolism within 3 months before the screening radiographic studies. • Ongoing infection > grade 2 NCI-CTCAE version 4.0 • Symptomatic brain metastasis(es) • Patients with a history of bleeding diathesis: Any haemorrhage or bleeding event at CTCAE Grade 3 within 4 weeks of the proposed start of study medication. • Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the patient’s participation in the study or evaluation of the study results. • Known hypersensitivity to any of the excipients of QV0 • Any gastrointestinal conditions that may prevent or interfere with the oral administration and gastrointestinal absorption of QV0 • Any medical condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study. • Unresolved toxicity higher than NCI-CTCAE (version 5.0) Grade 2 attributed to any prior therapy/procedure excluding alopecia. • Standard exclusionary conditions associated with standard of care treatment in the dose escalation phase, such as significant autoimmune diseases for immunotherapy or significant peripheral neuropathy and ototoxicity for cisplatin-based therapy.
Outcome results
None listed