The GVAX Cancer Vaccine Trial At the Dana Farber is a Phase I Trial of Vaccination with Autologous, Lethally Irradiated Tumor Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete GM-CSF in Adult and Pediatric Patients with Advanced Clear Cell Sarcoma, Translocation Associated Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children with Stage IV Melanoma
(released by Dana Farber/Harvard Cancer Center, Boston, Massachusetts)
This is a Phase I clinical trial being conducted at the Dana Farber/Harvard Cancer Center utilizing a previously established technique of tumor cell vaccination.
The scientific rationale involves surgically removing a patientâ€™s own (autologous) tumor cells and genetically altering them so that they secrete a protein called granulocyte-macrophage stimulating factor (GM-CSF). The â€œGM-CSF secreting tumor cells â€œ are then irradiated which prevents them from being able to grow, but allows them to still secrete GM-CSF. Once injected under the patientâ€™s skin, these vaccine cells secrete GM-CSF, which attracts cells of the immune system to the site. In theory, the immune system cells become activated and â€œseeâ€ the tumor cells as â€œforeignâ€. The immune system cells attack the tumor cells at the site as well as recruit other cells of the immune system to attack tumor cells elsewhere in the body.
It is important to understand that this is a Phase I trial, meaning that the principal aims of the study are to demonstrate the safety and feasibility of the approach. It is possible that patients treated on this protocol will have no benefit from the therapy, and will be exposed to the risk of an experimental treatment.
A team of physician-scientists at DFCI/HCC has worked for over ten years in the development of cancer vaccine strategies utilizing GM-CSF secreting tumor vaccines. Observations from the previous studies conducted here have demonstrated that this cancer vaccine elicits a strong immune response in patients at the site of injection and in some cases stimulates an immune response against the cancer cells in other parts of the patientâ€™s body. In the current study, we have incorporated the experience that we have accumulated in several cancer vaccine studies in patients with metastatic melanoma, lung cancer and ovarian cancer.
About 36 people will take part in this study through the Dana-Farber/Harvard Cancer Center. Fifteen of these patients will be children with melanoma, and the other 21 patients will be adults and children with either alveolar soft part sarcoma, clear cell sarcoma or a kind of kidney cancer that children get, known as translocation associated renal cell carcinoma.
This trial is only available to patients who come to the Dana-Farber Cancer Institute for evaluation, surgery and study treatment. Patients from all over the world are eligible to receive the study treatment provided they are able come to Boston. No specific funding is available at this time for patients who must travel to Boston or for patients whose insurance coverage will not pay for surgery and hospital visits. The total time from surgery to completion of the trial is approximately 3 months. Following surgery, patients receive vaccination once weekly for 3 weeks and then every other week for 3 weeks. Patients must be deemed healthy enough to participate in this clinical trial, as it is an experimental therapy and it is possible that very ill patients will become sicker before they are able to complete the trial.
The main contact for this trial, for both pediatric and adult patients, is John Goldberg, M.D. He can be reached at John_Goldberg@dfci.harvard.edu.
Please note that it is necessary to have the patientâ€™s physician consult with Dr. Goldberg to determine if he or she might be considered eligible for the trial.
Thank you for your interest in this exciting new clinical trial, as we continue our work to learn more about the treatment of these very challenging diseases.