Glioblastoma MultiformePhase 1/2NCT00479765
A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma
A Phase 1/2 study testing OncoGel (ReGel/Paclitaxel) in people with Glioblastoma Multiforme and Brain Neoplasms, run by Boston Scientific Corporation at 5 sites in United States.
Trial summary
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme, Brain Neoplasms
- What is being tested?
- OncoGel (ReGel/Paclitaxel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2007to Oct 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 to less than 70 years of age
- Radiological evidence on MRI of progressive recurrent malignant glioma that is unilateral, unifocal, supratentorial and of the minimum tumor volume as required per dose level assignment
- Tumor must have a solid contrast enhancing component
- Gross total resection >95% of the recurrence must be planned
- Must have received prior conventional radiation therapy completed >4 weeks before Study Day 1 (ie, day of craniotomy and OncoGel administration)
- Previous cytoreductive surgery or biopsy with pathologic diagnosis of glioblastoma multiforme
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- Diagnosis of glioma at the time of debulking surgery for recurrence (by frozen section or squash preparation)
- Life expectancy > 2 months
- KPS greater than or equal to 70
- Using appropriate birth control, if female of child-bearing potential;
- Able and willing to participate in the study by signing the informed consent document
Who cannot join
- Contrast-enhancing tumor crossing the midline
- Multifocal or non-contiguous tumor resulting in multiple resection cavities
- Evidence of tumor dissemination (ependymal, leptomeningeal)
- Tumors that result in a lobectomy or after resection leave an insufficient residual cavity to receive the expected OncoGel volume
- Expected communication between the ventricle and resection cavity that cannot be repaired
- Involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve or any other cranial nerve
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- Significantly increased intracranial pressure
- Received any type of stereotactic radiosurgery or brachytherapy with the exception of a stereotactic radiosurgery boost as part of the initial radiation therapy
- History of seizures refractory to two or more anticonvulsant medications co-administered at therapeutic levels
- Impaired organ function as evidenced by clinically significant laboratory parameters including but not limited to the following: Hepatic Status: Bilirubin >2.0 mg/dL; Aspartate transaminase (AST) >2.5 times the normal limit; Alanine aminotransferase (ALT) >2.5 times the normal limit. Hematopoietic Status: Absolute neutrophil count (ANC) <1500mm3; Platelet count <100,000/mm3; Hemoglobin < 10 g/dL. Hemostatic: Prothrombin Time (PT) or INR above normal range; Partial Thromboplastin Time (PTT) above normal range; Bleeding Time outside normal range (if performed by hospital). Renal Status: Serum creatinine >2 mg/dL.
- Contraindication to MRI
- Receipt any chemotherapeutic agent within 28 days of Study Day 1 or nitrosourea within 6 weeks of Study Day 1
- Received any intracerebral investigational agent
- Receipt of another investigational drug or device within 28 days of the planned surgery
- Known history of allergy to paclitaxel or any other component of OncoGel
- Pregnant or lactating
- Concurrent life-threatening disease
- Any medical condition or other circumstance that, in the opinion of the Investigator, would make the subject unlikely or unable to successfully complete the study, or would interfere with analysis of study results
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Johns Hopkins University
Baltimore, Maryland, 21231
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
The University of Chicago Brain Tumor Center
Chicago, Illinois, 60637
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
University of Rochester Medical Center
Rochester, New York, 14642
About this study
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.
Read the detailed description
This study is for patients with recurrent glioblastoma multiforme. Because most recurrences are in the area of the original resection, local delivery of a chemotherapeutic agent may prevent or delay additional recurrences. Paclitaxel has demonstrated activity against 9L glioma tumor lines, but has poor central nervous system penetration after intravenous administration. OncoGel is a new formulation of paclitaxel in a bioerodible gel that can be administered directly to the brain, thereby bypassing the blood-brain barrier.
- Conditions
- Glioblastoma Multiforme, Brain Neoplasms
- Being tested
- OncoGel (ReGel/Paclitaxel)
- Keywords
- glioblastoma multiforme, recurrent, Phase 1, Phase 2, Phase I, Phase II, brain, cancer, paclitaxel, intracranial, tumor, local, chemotherapy, brain tumor, brain cancer, glioma, OncoGel
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Recurrence, Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoGel (ReGel/Paclitaxel)Drug
OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel Receives: Drug: OncoGel (ReGel/Paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Dose-limiting Toxicities (DLTs)
any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Sponsor business decision, not based on safety or efficacy data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maciej S Lesniak, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479765
- Sponsor's protocol ID
- PR016-CLN-pro002
- Other IDs
- OGL-109
- Status last verified
- Jun 2022
- First submitted
- 24 May 2007
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma
- ClinicalTrials.gov ID
- NCT00479765
- Acronym / sponsor ID
- PR016-CLN-pro002
- Conditions
- Glioblastoma Multiforme, Brain Neoplasms
- Keywords
- glioblastoma multiforme, recurrent, Phase 1, Phase 2, Phase I, Phase II, brain, cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision, not based on safety or efficacy data
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.
Detailed description
This study is for patients with recurrent glioblastoma multiforme. Because most recurrences are in the area of the original resection, local delivery of a chemotherapeutic agent may prevent or delay additional recurrences. Paclitaxel has demonstrated activity against 9L glioma tumor lines, but has poor central nervous system penetration after intravenous administration. OncoGel is a new formulation of paclitaxel in a bioerodible gel that can be administered directly to the brain, thereby bypassing the blood-brain barrier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OncoGel (ReGel/Paclitaxel)OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 to less than 70 years of age
- Radiological evidence on MRI of progressive recurrent malignant glioma that is unilateral, unifocal, supratentorial and of the minimum tumor volume as required per dose level assignment
- Tumor must have a solid contrast enhancing component
- Gross total resection >95% of the recurrence must be planned
- Must have received prior conventional radiation therapy completed >4 weeks before Study Day 1 (ie, day of craniotomy and OncoGel administration)
Key exclusion criteria (18 listed)
- Contrast-enhancing tumor crossing the midline
- Multifocal or non-contiguous tumor resulting in multiple resection cavities
- Evidence of tumor dissemination (ependymal, leptomeningeal)
- Tumors that result in a lobectomy or after resection leave an insufficient residual cavity to receive the expected OncoGel volume
- Expected communication between the ventricle and resection cavity that cannot be repaired
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 |
|---|---|---|
| OncoGel (ReGel/Paclitaxel)OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection. | Drug | 1 |
Primary outcome
Occurence of Dose-limiting Toxicities (DLTs)
Time frame: 8 weeks
any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maciej S Lesniak, MD principal investigator
University of Chicago
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OncoGel (ReGel/Paclitaxel) in people with Glioblastoma Multiforme and Brain Neoplasms, run by Boston Scientific Corporation at 5 sites 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 11 inclusion and 18 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 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurence of Dose-limiting Toxicities (DLTs) (time frame: 8 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 22 Jun 2022.