Austin, Ludwig to run PII melanoma vaccine trial

The Austin Health/Ludwig Institute of Cancer Research (LICR) joint oncology unit has received a grant of US$600,000 from US-based cancer charity, the Cancer Research Institute (CRI), to conduct an international Phase II clinical trial that will test the effectiveness of a therapeutic vaccine for melanoma.

The trial will be conducted by the Cancer Vaccine Collaborative, which was established by the Cancer Research Institute and LICR to systematically analyse cancer vaccines in humans to look at immunological responses in a coordinated global effort.

The vaccine combines the cancer-specific protein NY-ESO-1, which was discovered at the LICR with CSL's ISCOMATRIX adjuvant, and will be tested on patients with advanced malignant melanoma.

"The results from the initial trial showed that the vaccine was able to induce a patient's own immune system to target the tumour. The next crucial step is to perform a Phase II trial that will tell us whether this immunological response translates into a real clinical benefit for the patient," said Dr Jill O'Donnell-Tormey, executive director of CRI.

O'Donnell-Tormey said a number of Phase I trials funded by the CRI had been performed to provide information about the immune response generated by different vaccine formulations in a variety of cancers. Standardised laboratory testing protocols were used to ensure that results from different trials could be compared.

"We can't vaccinate against cancer until we know how to immunise, and we can't immunise until we understand the immune response," she said.

The 100-patient Phase II trial is expected to start in December 2004, or January next year, once the final protocol is approved. It will be completed about 18 months after the last patient is enrolled. Investigators will be looking to see if median survival times are prolonged in vaccinated patients.

The director of the joint oncology unit, Assoc Prof Jonathan Cebon, said the trial was the first of a cancer vaccine to be funded and sponsored by an academic partnership rather than industry. He said the results of the study would feed back into the development partnership between LICR and CSL.