SCHOOL OF MEDICINE • DEPARTMENT OF MEDICINE

Faculty members within the Division of Hematology and Oncology are heavily involved in identification of novel therapies for advanced tumors as well the discovery of novel prognostic and predictive biomarkers. Many of these efforts are outlined in other Research Theme descriptions (e.g. Hematology, Genetics and Genomics, Hematologic Malignancies, Health Services).

The Phase I Program is an important highlight of the Cancer Center and Division. On average 15-20 phase I trials are active at any given time with annual accrual of 70-80 patients. This program is lead by Dr. Afshin Dowlati who is principal investigator of an NCI Phase I grant for early therapeutics development.  The program emphasizes collaboration with the NCI, the development of “in-house” agents (such as methoxyamine) and pharmaceutical collaboration. Our disease-specific faculty actively participate and lead Phase I trials (e.g. Drs. Hoimes, Markowitz).  The Case Comprehensive Cancer Cetner is one of only 7 centers nationally to hold both U01 and N01 cancer drug development grants from CTEP.

The Breast Cancer Program (Drs. Baar, Owusu [see Health Services section], Silverman) has an active clinical trials program with 9 investigator-initiated, 4 Industry-sponsored and 11 Cooperative group trials either open or going through the regulatory process. One investigator initiated trial was written and are in the process of activation.  One of current active trials is “Denditic cell vaccine therapy against stromal peptides in breast cancer” by Baar (recently awarded a Komen Foundation grant for this research). Dr. Baar’s program encompasses the development of investigator-initiated trials in breast cancer vaccines. He has undertaken a clinical trial of MUC-1 peptide vaccination in patients who have completed treatment for early-stage triple-negative breast cancer (BC) (CASE 16107). His Komen award will support a prospective clinical trial of an autologous dendritic cell-based vaccine intended to generate T cell cytotoxic immunity against tumor blood vessel associated antigens..A Breast Program member sits on the ECOG breast committee (Silverman) and is the designated PI’s for two Intergroup studies (NSABP – B47 and B43).

The Breast Program membership includes a multidisciplinary team of specialist and allied professionals. Many have active research studies ongoing - Plecha (tomosynthesis, breast PET-MRI), Lyons (radiation dose delivery, re-irradiation), Baar (immunotherapy, notch inhibitors), Shenk (high risk clinic, preoperative therapy), Silverman (U/S guided node biopsy, cardiac risk, survivorship, CNS metastases). In addition, a number of members of other departments are actively involved in breast cancer research projects Keri – (breast cancer signaling pathways, novel therapeutics), Schiemann (metastasis, TGFb signaling), Thompson (breast density, miRNAs), Gilmore (preop therapy/genomics, primagrafts, CNS metastases), Jackson (normal mammary biologic, stem cells, stromal-epthelial interactions), Narla (novel therapeutics, genetic susceptibility) DeFeo (ovarian-TNBC studies). Several resources have been developed to facilitate translational research within the program, including primagrafts from breast cancer samples, and several annotated tissue cohorts. These include a cohort of CNS metastases and matched primary samples with a tissue microarray and nucleic acid extraction for gene expression and mutation profiling. In addition, infrastructure is being developed to database all new patients with collection of biospecimens and clinical data. The activities of this group will form the basis for the new developing Breast Cancer Program in the Case Comprehensive Cancer Center.