Last updated on November 2016

Safety and Efficacy of Intra-Arterial Ad-p53 in Liver Metastases of Solid Tumors


Brief description of study

This is a Phase 1 study of the combination of Ad-p53 administered intra-arterially in combination with oral metronomic capecitabine in patients with unresectable, refractory liver metastases of colorectal carcinoma (CRC) and other solid tumors, including primary hepatocellular carcinoma (HCC). This safety study has a standard 3+3 design. The Maximum Tolerated Dose (MTD) will be determined as well as the general safety and preliminary efficacy using RECIST 1.1 and Immune-Related Response Criteria. CEA levels will also be followed.

Detailed Study Description

This is a Phase 1 study of the combination of Ad-p53 administered intra-arterially in combination with oral metronomic capecitabine in patients with unresectable, refractory liver metastases of colorectal carcinoma (CRC) and other solid tumors, including primary hepatocellular carcinoma (HCC). This safety study has a standard 3+3 design, with dosing following the initial cohort determined by MTD and DLT criteria as well as safety and tolerance. Patients will be followed for adverse events and preliminary efficacy. The Maximum Tolerated dose (MTD) will be determined as well as the general safety and preliminary efficacy using RECIST 1.1 and Immune-Related Response Criteria. CEA levels will also be followed. Biomarker testing of archival or fresh tissue is performed during the study. Patients will undergo a maximum of 2 8-week cycles, with scans every 8 weeks. No additional biopsies are planned following Screening. Enrollment will be up to 24 patients.

Clinical Study Identifier: NCT02842125

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Vivek Subbiah, MD

MD Anderson Cancer Center
Houston, TX United States
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