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Due to the small number of children and adolescents with cancer, new drugs for this population are often an afterthought for new drug development. Mary Crowley wants to play a role in changing this afterthought to a fore thought, initially by focusing on Ewing's Sarcoma, an aggressive, malignant tumor of bone and soft tissue most commonly occurring in children, adolescents, and young adults. Two thirds of children diagnosed with advanced Ewing's Sarcoma will not survive with current treatments. The FDA has granted approval for Mary Crowley, based on their prior adult results, to expand the Phase 1 FANG™ personalized vaccine clinical trial for Ewing's Sarcoma patients.
The investigational vaccine is constructed to incorporate the unique genetic characteristics of each child's cancer. A portion of the patient's cancer tissue that is removed during a surgical procedure is used to manufacture of a triple acting vaccine. This triplex vaccine is designed to: educate the patient's immune system to identify tumor cells as foreign bodies; enhance the immune system by increasing the production of tumor attacking T cells; and block the enzyme Furin to inhibit the activity of immunosuppressor proteins. The manufacturing process of the vaccine is completed in approximately 4 weeks by a biotech company in Dallas. After the manufacturing process is completed, the patient is evaluated for participation in a clinical trial to receive the monthly vaccine injections over a 6-12 month period.
For additional information and potential enrollment, contact lead investigator Dr. Marizio Ghisoli, M.D. at 972-566-6647.
Dr. Ghisoli specializes in pediatric hematology/oncology and stem cell transplantation, with a special interest in solid tumors (sarcomas of the bone and muscle), leukemia and lymphomas, and hematologic disorders. Dr. Ghisoli is board certified in pediatric oncology, having trained at University of Texas MD Anderson Cancer Center in Houston, Texas. He is the lead investigator for the Phase 1 Ewing's Sarcoma FANG™ clinical trial currently enrolling patients. Dr. Ghisoli has committed his professional career to providing high quality and compassionate care to children and adolescents with cancer and other hematologic disorders.
FANG™ Ewing's Sarcoma Trial
A Phase I Trial of bi-shRNAfurin & GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer (FANGTM).
A Phase 1 clinical trial of the FANG™ personalized immune therapy is currently open for Ewing's Sarcoma patients. This investigational therapy is constructed to incorporate the unique genetic characteristics of each patient's cancer. A portion of the patient's cancer tissue that is removed during a surgical procedure is allocated for the manufacture of a "triple" vaccine. A “triplex" vaccine is unique and designed to educate the patient's immune system to identify tumor cells as foreign bodies; to enhance the immune system to increase the production of tumor attacking T cells; and to block the enzyme Furin to inhibit the activity of immunosuppressor proteins. The manufacturing process is successful in approximately half of cases and is complete in approximately 4 weeks. After the manufacturing process, the patient is evaluated for participation in a clinical trial to receive the monthly vaccine injections over a 6-12 month period.
Additional information can also be found on the Mary Crowley website.