Feb. 13, 2004 Philadelphia, PA – Researchers at the Abramson Cancer Center of the University of Pennsylvania have begun a Phase I clinical trial to evaluate the effectiveness of a telomerase peptide as a possible vaccine against breast cancer. The study will measure potential tumor cell shrinkage in patients after an immune response has been triggered to an antigen – the telomerase peptide – found in more than 90 percent of breast cancer tumors.
The study is made possible through a unique $500,000 grant from the "Avon-NCI Progress for Patients" Awards program, a special private-public partnership between the Avon Foundation, Inc. and the National Cancer Institute (NCI) dedicated to accelerating early phase clinical research into promising therapies.
"This is the first clinical study to use a telomerase peptide as a possible vaccine against breast cancer," said lead researcher Robert Vonderheide, MD, DPhil, an assistant professor at the Leonard and Madlyn Abramson Family Cancer Research Institute at the University of Pennsylvania. "Our hope is that the immune response will kill the cancer and improve the health of patients."
Twenty-eight patients with metastatic breast cancer will be enrolled in the study, which is expected to last two years. Patients will be injected with one of three escalating doses of the telomerase antigen in combination with adjuvant therapies (granulocyte-macrophage colony stimulating factor, GM-CSF) over a period of seven months. The immune and tumor response to the telomerase-based vaccine will be monitored over the duration of the study and compared to a control response to an injection of cytomegalovirus peptide.
Avon/NCI-Funded Breast Cancer Vaccine Trial…
The results of an earlier feasibility study – also led by Vonderheide and published in the February 1st edition of the journal Clinical Cancer Research – showed immune responses with little toxicity in seven breast and prostate cancer patients after they were injected with small amounts of a similar telomerase peptide vaccine.
"One breast cancer patient in the earlier study showed temporary tumor regression, prompting us to accelerate research into the possibility of a vaccine," said trial principal investigator Susan Domchek, MD, a breast medical oncologist at the Abramson Cancer Center and assistant professor at Penn's School of Medicine.
Patients can obtain further information about the trial by calling: 215-615-3360, or toll free at 1-800-789-Penn (7366).
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