PILOT--CLINICAL RESEARCH

Wake Forest University, Winston Salem NC

Investigators

Linked publications & trials

Abstract

The Clinical Research Program is organized around three themes: Therapeutic Modulation, Bioanatomic Imaging, and Alternative & Complementary Therapies. Therapeutic Modulation focuses on novel treatments translated from CCCWFU laboratories into the clinic. One area of active investigation is Diphtheria toxin fusion proteins. Based on in vitro and in vivo studies from CCCWFU laboratories, patients with relapsed/refractory acute myeloid leukemia are receiving Diphtheria toxin-GMCSF fusion proteins in a Phase I study. Ongoing laboratory studies of IL-3 Diphtheria toxins and EGF Diphtheria toxins should translate into Phase I clinical trials in acute phase CML and recurrent glioblastoma. Gemcitabine radiosensitization and oxaliplatin radiosensitization are other active areas. Bioanatomic Imaging is based on the use of biologic/physiologic imaging of cancer with modalities such as magnetic resonance spectroscopy and positron emission tomography, and novel anatomic imaging such as virtual endoscopy Areas of active investigation include bioanatomic radiation therapy treatment planning using conventional CT and MRI scans fused with F-18 Misonidazole (i.e., hypoxia) and O15 water (i.e., perfusion) PET scans. Virtual reality computer technology is being used in the colon for the detection of colon polyps. High resolution full breast direct digital mammography is technology being investigated in comparison to conventional screen-film mammography. Alternative & Complementary Therapies utilize pharmacologic interventions to reduce the morbidity and/or mortality of cancer. A series of Phase II randomized, placebo on controlled, double blind studies are being conducted by the CCCWFU. Megestrol acetate is being studied in primary lung and head & neck cancer patients with localized disease treated for cure with radiation therapy. Erythropoietin is also being investigated in lung cancer patients. Another study in patients with primary or metastatic brain tumors three months or more following radiation therapy (with or without surgery and chemotherapy) randomizes patients to a six month course of placebo, Gingko Biloba, or donepezil (Aricept). Other alternative and complementary drugs are being investigated, such as methylphenidate in primary/metastatic brain tumor patients undergoing a cranial radiation therapy, and co-enzyme Q10 in cancer patients with fatigue. The CCCWFU has obtained a NIH-NCI Research Base grant. There are 4 regional CCOP's participating in the CCWFU Research Base, resulting of a network of 20 regional community cancer centers were are the only NCI Designated Cancer Center which is funded as a Research Base to conduct both cancer treatment and cancer control clinical trials.