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Clinical Trial Summary

The study will use an Ommaya reservoir that drains into brain metastases to deliver activated, autolous dendritic cells to the tumor lesion, for patients who are 18 - 75 years old who have brain metastases from either lung cancer or breast cancer. The primary objective of the study is to evaluate the safety and feasibility of administering DCVax-Direct to patients with metastatic tumors in the brain. The secondary objectives are to determine tumor response, the rate of intracranial recurrence (IR), the rate of neurologic deaths, decline in neuro-cognitive functioning and overall survival. Approximately 10 patients with injectable metastatic brain tumors will be enrolled initially in a dose escalation scheme, with the expectation to enroll a total of 24 patients.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03638765
Study type Interventional
Source Northwest Biotherapeutics
Contact Marnix L Bosch, PhD
Phone 2404979022
Email marnix@nwbio.com
Status Not yet recruiting
Phase Phase 1
Start date November 2018
Completion date December 2020

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