Melanoma Clinical Trial
01 October 2004
In 2004 the Malaghan Institute and Wellington Hospital Blood & Cancer Centre, in collaboration with the Queensland Institute of Medical Research, launched a phase III melanoma vaccine clinical trial.
The advantage of a vaccine-based approach to cancer treatment over conventional therapies such as chemotherapy and radiotherapy is that it has minimal side-effects.
Tumour cells from stage three melanoma patients were used to prepare tailor-made vaccines that were then administered to the patients over a two year period. The vaccine was created for each patient from their own biopsied tumour tissue, which was used to activate immune cells isolated from their blood. The placebo was not activated with tumour but was also made from the patient's blood cells.
Patients eligible for entry into the trial underwent a series of 13 vaccinations; five vaccinations, one a fortnight, were given over an eight week period (priming phase), followed by one booster vaccination every subsequent three months for two years.
Based on findings from earlier phase I/II clinical trials at the Queensland Institute of Medical Research, the phase III trial aimed to have 200 patients participating in the study, 20 of which were to come from New Zealand. Statistical evaluation of results at the mid-point of the trial (100 patients involved), however, revealed that there were not going to be enough patients involved in the trial to show a statistically significant improvement in the health of the individuals being treated and the trial had to be stopped. It is important to note that the trial wasnt stopped because it hadnt worked and the outcome reflects the rigours and difficulties of conducting large multi-centre clinical trials with patients in late stage disease.
We are now in the process of reformulating the original vaccine protocol based on preliminary findings of the phase III trial and on promising new data from our basic cancer immunotherapy research programme.