Spots Global Cancer Trial Database for Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
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Trial Identification
Brief Title: Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
Official Title: A Phase Ib Clinical Trial Evaluating DCVax-Direct, Autologous Activated Dendritic Cells for Intratumoral Injection, in Patients With Unresectable Brain Metastases From Breast- or Non-Small Cell Lung Cancer
Study ID: NCT03638765
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Jacksonville, Florida, United States
Contact Details
Name: Alfredo Quinones Hinojosa, MB
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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