Have any of you taken part in a clinical trial during treatment? By this I mean a clinical trial for altruistic reasons to help future patients when the benefit to you is uncertain?
This is what we talked about at the Auckland meeting on 20 February. Auckland oncologist Andrew Macann presented a research idea to us involving an anti-hypoxia prodrug and mild, targeted radiotherapy.
His research is called a “window of opportunity” trial where patients are given experimental treatment during the 4-week waiting period between the multi-disciplinary meeting and surgery.
The “prodrug” developed in the Auckland Cancer Society Research Centre opposite Auckland Hospital is called Tarloxotinib. As a prodrug it is not like chemotherapy which carpet bombs your body but more like a guided missile that explodes when it hits a hypoxic area of the body. Hypoxic areas are those short of oxygen and are found in cancer tumours where the chaotic blood supply is poor but some “bad, bad, bad” cancer cells have survived. These hardy cells are the ones likely to resist standard treatment. Tarloxotinib will hopefully destroy them.
It is hoped that a mild but very targeted dose of radiation will attack the rest of the cells in the tumour and that there might be a synergy between the drug and radiation.
This has not been tried on humans before (in NZ at least) so it’s experimental. Surgery and any later treatment will go on as normal. The aim of the trial is NOT to upset normal treatment.
The trial will include two special MRIs before and after. These are called OE-MRIs (Oxygen Enhanced MRIs). There is a machine in the research centre that has the software available to give images of hypoxic areas in the tumour which then have to be sent to Manchester, UK, for analysis. The team will have to move fast to get the patient’s consent, do the first MRI, have a mask made, give the drug and radiotherapy and then do a second MRI.
Which patients will be recruited for this trial? It is suitable for patients who have non-HPV tumours in the mouth and throat which are quite advanced and have a 50/50 chance of recurring. HPV related HNC tumours are not so suitable because they usually respond well to standard treatment even at an advanced stage.
Our group suggested questions that future patients might want answered. We were generally in favour of a trial like this not only for the future benefit of science but because we find the four week (or more) waiting period horrible and it might be nice for these patients to fill that time with regular contact with a friendly research team and the faint hope the new treatment might help them too.NOTE: The trial is in the design phase seeking consultation from patient advocates. A funding application is in progress to determine if the study will proceed.
 Window of opportunity study prior to surgery in advanced HPV negative head & neck
squamous cell carcinoma
 Advanced p16-ve HNSCC oral cavity, oropharynx, larynx or hypopharynx planned for definitive surgical resection