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Cancer Vaccine

Experimental Treatment for Brain Tumor

Phase 1
Waitlist Available
Led By Alfredo Quinones Hinojosa, MB
Research Sponsored by Northwest Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks through study completion, an average of 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Brain Tumor
  • Lung Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety is assessed graded according to NCI CTC. The overall incidence of adverse events is calculated.
Secondary outcome measures
intracranial recurrence rate
overall survival
tumor response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental TreatmentExperimental Treatment1 Intervention
Intratumoral injection of activated, autologous dendritic cells (DCVax-Direct) in brain metastases from lung cancer or breast cancer

Find a Location

Who is running the clinical trial?

Northwest BiotherapeuticsLead Sponsor
7 Previous Clinical Trials
444 Total Patients Enrolled
Mayo ClinicOTHER
3,207 Previous Clinical Trials
3,766,836 Total Patients Enrolled
Alfredo Quinones Hinojosa, MBPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

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~4 spots leftby Apr 2025