Back to resultsSuper-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
Primary Purpose
Glioblastoma Multiforme
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of GBM
- Grade IV GBM tumors that have recurred after total resection
- Age > 18 years
- At least four weeks following any recent surgery
- Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.
- No IV chemotherapy for three weeks prior to treatment under this research protocol and no external beam radiation for four weeks prior to treatment under this research protocol.
- Patients must have adequate hematologic reserve
- Pre-enrollment coagulation parameters (PT and PTT) must be adequate.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intra Arterial Bevacizumab
Arm Description
Repeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety
The frequency of adverse events will be quantified until disease progression or death.
Secondary Outcome Measures
Tumor Response
Full Information
NCT ID
NCT02285959
First Posted
November 4, 2014
Last Updated
August 8, 2022
Sponsor
Global Neurosciences Institute
1. Study Identification
Unique Protocol Identification Number
NCT02285959
Brief Title
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
Official Title
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Global Neurosciences Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra Arterial Bevacizumab
Arm Type
Experimental
Arm Description
Repeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety
Description
The frequency of adverse events will be quantified until disease progression or death.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Tumor Response
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of GBM
Grade IV GBM tumors that have recurred after total resection
Age > 18 years
At least four weeks following any recent surgery
Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.
No IV chemotherapy for three weeks prior to treatment under this research protocol and no external beam radiation for four weeks prior to treatment under this research protocol.
Patients must have adequate hematologic reserve
Pre-enrollment coagulation parameters (PT and PTT) must be adequate.
Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Exclusion Criteria:
Women who are pregnant or lactating.
Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Facility Information:
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Binning
Email
MBinning@gnineuro.org
12. IPD Sharing Statement
Learn more about this trial
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
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