Glioblastoma MultiformePhase 1NCT01526837
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
A Phase 1 study testing Avastin in people with Glioblastoma Multiforme, run by Brain & Spine Surgeons of New York at 1 site in United States.
Trial summary
This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Avastin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent Glioblastoma
- At least 12 weeks expected survival (KPS >60)
- 18 years of age or older
- Able and willing to participate
Who cannot join
- Any prior diagnosis of any other cancer or other concurrent malignancy.
- Planned use or current use of other investigation therapy.
- Systemic autoimmune disease
- HIV positive
- Concurrent life threatening disease
- Impaired organ function
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- Active infection
- Inadequately controlled hypertension
- Congestive heart failure
- Myocardial infection/unstable angina within 6 months
- Stroke within 6 months
- Pheripheral vascular disease
- History of abdominal fistula/gastrointestinal performation
- Non-healing wound
- Coagulation disease
- Known allergy to study treatments
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain & Spine Surgeons of New York
White Plains, New York, 10604
About this study
Official title: A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Avastin
- Keywords
- Brain tumor, GBM, Brain cancer
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab (Avastin) | Experimental | Open-label, dose-escalating study conducted in cohorts of 1-3 patients treated at increasing doses of bevacizumab in the dose range of 1-25mg/Ml. A maximum of 24 subjects will be treated in this study (up to 8 cohorts of 3 subjects). Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Measured: 4 weeks
Secondary outcomes (2)
Number of Adverse Events
All adverse events will be recorded in the case report form.
Measured: 12 months
Progression Free Survival
Patients will be followed for survival as well as disease progression for 12 months after treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Investigators decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain & Spine Surgeons of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Abrahams, M.D., Brain & Spine Surgeons of New York
- Investigators
- John Abrahams, MD, Principal investigator, Brain & Spine Surgeons of New YorkJan Strack, Study director, BSSNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526837
- Sponsor's protocol ID
- BSSNY-B-001
- Status last verified
- Jul 2017
- First submitted
- 5 Nov 2011
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence
- ClinicalTrials.gov ID
- NCT01526837
- Acronym / sponsor ID
- BSSNY-B-001
- Conditions
- Glioblastoma Multiforme
- Keywords
- Brain tumor, GBM, Brain cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Brain & Spine Surgeons of New YorkUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab (Avastin) | Experimental | Drug: AvastinOpen-label, dose-escalating study conducted in cohorts of 1-3 patients treated at increasing doses of bevacizumab in the dose range of 1-25mg/Ml. A maximum of 24 subjects will be treated in this study (up to 8 cohorts of 3 subjects). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recurrent Glioblastoma
- At least 12 weeks expected survival (KPS >60)
- 18 years of age or older
- Able and willing to participate
Key exclusion criteria (17 listed)
- Any prior diagnosis of any other cancer or other concurrent malignancy.
- Planned use or current use of other investigation therapy.
- Systemic autoimmune disease
- HIV positive
- Concurrent life threatening disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvastinTopical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml. | Drug | bevacizumab (Avastin) |
Primary outcome
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Time frame: 4 weeks
2 secondary outcomes
Number of Adverse Events
Time frame: 12 months
Progression Free Survival
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Investigators decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Abrahams, MD principal investigator
Brain & Spine Surgeons of New York
Jan Strack study director
BSSNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avastin in people with Glioblastoma Multiforme, run by Brain & Spine Surgeons of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigators decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.