23.0638:  A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors. 

Principal Investigator: Akshitkumar Mistry, MD 

Phase:  III 

Description:  This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRS 3-4 weeks following metastatic tumor resection which is the current standard of care.

More Info:  https://clinicaltrials.gov/study/NCT04365374?term=NCT04365374&rank=1

23.0171:  A Phase 1b / 2 Open-label Study to Investigate the Safety, Tolerance and Efficacy of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide (TMZ) in Subjects With Recurrent or Newly Diagnosed Glioblastoma 

Principal Investigator: Akshitkumar Mistry, MD 

Phase:  I 

Description:  This multicenter, Phase 1b/2 study is being conducted to determine if the experimental cell therapy is safe, tolerable and can delay the return of cancer in patients with a newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard chemotherapy treatment temozolomide (TMZ). If there is a 25% or greater improvement in survival in this study then the therapy should be studied further. 

More Info:  https://clinicaltrials.gov/study/NCT05664243?term=INB-400&checkSpell=false&rank=1

22.0978:  A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced/Metastatic Solid Tumors

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

More Info:  https://clinicaltrials.gov/ct2/show/NCT05514444?term=NCT05514444&draw=2&rank=1

22.0676: A Phase I Trial of Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma

Principal Investigator: Donald Miller, MD, PhD

Phase: I

Description: The overall goal of this protocol is to characterize the safety and immunologic/genomic/metabolomic effects of neoadjuvant Pembrolizumab and Temozolomide in recurrent glioblastoma

22.0246:  Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or Fewer Brain Metastases from Small Cell Lung Cancer

Principal Investigator: Neal Dunlap, MD

Description:  The purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the stereotactic radiosurgery (SRS) helps to either slow the growth of cancer or stop it from coming back, compared to the usual approach. Doctors will also look to see if this new approach increases the life span of patients with this type of cancer, and if it helps with quality of life and cancer related symptoms. The usual approach for patients who are not in a study is treatment with whole brain radiation therapy alone (WBRT).

More info:  https://clinicaltrials.gov/ct2/show/NCT03550391?term=NCT03550391&draw=2&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.