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Spots Global Cancer Trial Database for DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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