NCT03638765

Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Northwest Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Metastases
• Lung Cancer Metastatic
• Breast Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	DCVax-Direct	activated, autologous dendritic cells

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2018-08-20
• Last updated: 2018-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study