Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Global Neurosciences Institute
Study ID
NCT02285959
Phase
PHASE1
Status
Unknown

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The high-grade malignant brain tumor glioblastoma multiforme (GBM) comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM. Initial therapy consists of surgical resection, external beam radiation or both. Currently, all patients experience a recurrence after this first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the concentration of drug delivered to the brain while sparing the body of systemic side effects. This technique threads a tiny catheter through the patient's femoral artery in the leg, up through the body and neck and into the brain. Once the catheter reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.

Key Dates

First listed
Nov 7, 2014
Start date
Jun 30, 2014
Status verified
Aug 2022
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intra Arterial Bevacizumab
    Repeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks

Primary Outcome Measure

Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
-PhiladelphiaPennsylvania-
Mandy Binning
[email protected]

Related Studies