None listed
Conditions
Brief summary
This study is investigating whether it is safe to administer curcumin packaged into small biological spheres called liposomes, to patients with malignant pleural effusion via a long-term chest drain directly into their pleural (lung) cavity. Who is it for? You may be eligible for this study if you are aged 18 years or older with an existing diagnosis of malignant pleural effusion, and you have failed to respond to approved systemic therapies (chemotherapy, immune therapy or molecular targeted therapies), or you have progressive cancers following initial response to these therapies. Study details The first three participants enrolled in this study will be administered 100 milligrams of curcumin per metre squared of body surface area, delivered directly into the tumour site via a pre-existing long-term chest drain, once only. If these participants do not present with any adverse effects, a second group of participants will be administered 200 milligrams of curcumin per metre squared of body surface area via their long-term chest drain. If the second group show no adverse effects a third, and final, group of participants will be administered 300 milligrams of curcumin per metre squared of body surface area. If the third group show no adverse effects, the maximum tolerated dose will not be reached within this pre-determined dose range, and the study will stop. All participants regardless of the maximum dose received will be asked to provide blood and tissue samples at ten different timepoints over the 25 weeks of the study. Additionally all participant will be asked to attend a total of 5 follow visits over the 25 weeks of the study. It is hoped this research will determine whether curcumin given directly into the tumour site is safe, and whether it has any therapeutic effect on the cancer in the pleural cavity that is causing an MPE.
Interventions
A single dose of liposomal curcumin, with the amount adjusted based on body mass (milligrams per metre squared (mg/m2)), will be administered to each participant by a respiratory clinician into their pleural cavity via an existing TIPC. Administration of the test drug will take approximately 15 minutes. Participants will not be randomised. Participants will receive ascending doses with each new cohort being administered the next dose. An initial cohort will be administered 100 mg/m2, a subsequen
A single dose of liposomal curcumin, with the amount adjusted based on body mass (milligrams per metre squared (mg/m2)), will be administered to each participant by a respiratory clinician into their pleural cavity via an existing TIPC. Administration of the test drug will take approximately 15 minutes. Participants will not be randomised. Participants will receive ascending doses with each new cohort being administered the next dose. An initial cohort will be administered 100 mg/m2, a subsequent group will receive a single dose of 200 mg/m2 of liposomal curcumin and a final group will be administered a single dose of 300 mg/m2 of liposomal curcumin.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older with an existing diagnosis of malignant pleural effusion on pleural biopsy or pleural fluid cytology in line with established standard practice for the diagnosis of malignant pleural effusion. 2. Individuals who have failed to respond to approved systemic therapies (chemotherapy, immune therapy or molecular targeted therapies), or who have progressive cancers following initial response to these therapies, and for whom no anti-tumour therapy of proven benefit is available at study enrolment. 3. People who have declined systemic therapies or are deemed not suitable for systemic therapies after consultation with a medical oncologist. 4. Recurrent symptomatic pleural effusion where insertion of a TIPC is clinically indicated. 5. Eastern Co-operative Performance Status 0 - 2. 6. Able to give signed informed consent. 4. People whose primary language is English.
Exclusion criteria
1. Women who are pregnant and/or breastfeeding, and/or of childbearing age not taking contraceptive measures to avoid pregnancy while participating in the study. 2. People under 18 years of age. 3. People with mental impairment, or an unstable medical condition other than cancer, that may interfere with their ability to provide informed consent or ability to cooperate and participate in the study. 4. People with evidence of active hepatitis. 5. People with a diagnosis of lymphoma or a haematological cancer. 6. People with a history of haemolytic anaemia. 7. People with unresolved toxicities from prior systemic anti-cancer therapy. 8. People with an unstable cardiac condition as determined by the study investigator.
Outcome results
None listed