The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors
Official Title: A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma (TARGET-I)
Study ID: NCT02197169
Brief Summary: Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant primary brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified, conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it may establish an active infection by replicating in and killing tumor cells.
Detailed Description: Enrollment has been completed for the randomized portion of the study with ongoing evaluation of tumor response and safety. No additional subjects will be randomized or receive interferon gamma (IFN-γ). The non-randomized portion of the study is open for screening and enrollment. Eligible subjects will receive a single intratumoral injection of DNX-2401 into a recurrent glioblastoma or gliosarcoma brain tumor using the Alcyone MEMS Cannula (AMC™) System (cannula). Tumor response and safety will be evaluated. After receiving DNX-2401, subjects will return to the clinic for study visits at regular intervals for safety monitoring, MRI scans and other assessments for up to 18 months. Thereafter, they will be followed closely for safety and survival.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moffitt Cancer Center, Tampa, Florida, United States
The Ohio State University, Columbus, Ohio, United States
Baylor University: Charles A. Sammons Cancer Center, Dallas, Texas, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
Name: Nam Tran, MD, PhD
Affiliation: Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Karen Fink, MD, PhD
Affiliation: Baylor University: Charles A. Sammons Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Vinay Puduvalli, MBBS
Affiliation: Ohio State University: James Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Frederick Lang, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR