Clinical Trial Data Encouraging.(Brief Article)

2002 JAN 23 - (NewsRx.com & NewsRx.net) -- Two Harvard Medical School oncologists working with Genzyme Molecular Oncology presented preliminary data showing both clinical and immunologic responses from melanoma and breast cancer vaccine trials.

The findings were presented at the annual American Society of Hematology (ASH) conference taking place in Orlando, Florida, December 2001.

Frank G. Haluska, MD, PhD, of the Massachusetts General Hospital and Dana-Farber Partners Cancer Care, is the lead investigator of a Phase I-II ex vivo antigen specific melanoma vaccine trial, which is the first one of its kind to use two melanoma antigens in a single vaccine. The approach uses a common viral vector to target dendritic cells, known as powerful immune stimulators, with the two antigens. The trial is fully enrolled and has 20 stage 3 and 4 melanoma patients with advanced disease currently being evaluated.

Haluska's preliminary findings show that this antigen specific approach was well tolerated by the 20 patients and demonstrated immunologic or clinical responses among fourteen of them. Five patients showed clinical evidence of an immune system response to the vaccine including three who experienced vitiligo - the loss of skin color in some parts of the body - and two who had asymptomatic changes in the retinas. The melanoma vaccine is directed against antigens that are also expressed in the skin and eyes.

Ten patients showed evidence of a specific immune response following vaccination that had not occurred earlier. Additionally, eight patients exhibited reactions at the sites of vaccination, further suggesting immunologic activity.

Further findings show that two patients had a measurable clinical response - one complete response and one partial response - and a third patient demonstrated stable disease. Two of the three showed evidence of reaction at the sites of vaccination. The patient with a complete response showed immunologic response to the vaccine that had not occurred beforehand. The patient with stable disease had both clinical immunologic response and evidence of a specific immune response to the vaccine that had not occurred earlier.

Joining Haluska at the ASH conference, David Avigan, MD, of Beth Israel Deaconess Medical Center, presented an interim clinical update on results from a tumor specific fusion trial in breast cancer being funded by Genzyme Molecular Oncology. In this study, a patient's dendritic cells are combined with their inactivated tumor cells in a chemical fusion process. The fused cells are then ...