GliomaPhase 2NCT00389090
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
A Phase 2 study testing Temozolomide and O6-Benzylguanine in people with Glioma and Astrocytoma, run by Keryx / AOI Pharmaceuticals, Inc. at 12 sites in United States.
Trial summary
This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Astrocytoma, Oligodendroglioma
- What is being tested?
- Temozolomide and O6-Benzylguanine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2006to Feb 2009
- Phase
- Phase 2
- 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
- Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
- Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
- Disease progression >= 12 weeks after the completion of any radiotherapy.
- If patient received chemotherapy or an investigational agent as part of their prior therapy, the patient must recover from all toxicities (<= Grade 1) prior to enrollment on this protocol.
- Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
- If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
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- KPS >= 70%.
- The following laboratory results:
- Absolute neutrophil count >= 1500 cells/microliter
- Platelet count >= 100,000 cells/microliter
- SGOT <= 2.5 x ULN
- Serum creatinine <= 1.5 x ULN
- Signed informed consent approved by Institutional Review Board.
- If sexually active, patients will take contraceptive measures for the duration of the treatment.
- For patients on corticosteroids, they must have been on a stable dose 1 week prior to baseline MRI and the dose should not be escalated over entry dose level, if clinically possible.
Who cannot join
- Pregnant or breast feeding women.
- Prior treatment with O6-BG plus temozolomide in combination.
- Active infection requiring intravenous antibiotics.
- Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients unwilling or unable to comply with the protocol.
- Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
- Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
AOI Pharmaceuticals Investigative Site
Chicago, Illinois, 60611
AOI Pharmaceuticals Investigative Site
Dallas, Texas, 75246
AOI Pharmaceuticals Investigative Site
Durham, North Carolina, 27710
AOI Pharmaceuticals Investigative Site
Evanston, Illinois, 60201
AOI Pharmaceuticals Investigative Site
Greenville, South Carolina, 29605
AOI Pharmaceuticals Investigative Site
Houston, Texas, 77024
AOI Pharmaceuticals Investigative Site
Lexington, Kentucky, 40536
AOI Pharmaceuticals Investigative Site
Los Angeles, California, 90033
AOI Pharmaceuticals Investigative Site
Louisville, Kentucky, 40202
AOI Pharmaceuticals Investigative Site
Minneapolis, Minnesota, 54407
AOI Pharmaceuticals Investigative Site
Orlando, Florida, 32804
AOI Pharmaceuticals Investigative Site
Salt Lake City, Utah, 84132
About this study
This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Read the detailed description
This open-label, multicenter, phase II trial will assess the antitumor activity and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be enrolled in this study. Total accrual on this study will not exceed 116 patients. The patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning immediately after the first bolus infusion and continuing until immediately prior to the last bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients may receive treatment at the same dose level until appearance of significant treatment-related toxicities, disease progression or withdrawal of consent.
Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for the duration of therapy, using physical and neurological examinations and diagnostic imaging.
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma, Oligoastrocytoma
- Being tested
- Temozolomide and O6-Benzylguanine
- Keywords
- temozolomide resistant, anaplastic glioma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide and O6-BenzylguanineDrug
Also called temodar
O6BG + Temozolomide
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide + O6BG | Experimental | Not described Receives: Drug: Temozolomide and O6-Benzylguanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
best objective response rate
Measured: Month 1, 2 and every 2 months thereafter.
Secondary outcomes (3)
Safety Assessment
Measured: Month 1, 2 and every 2 months thereafter
progression-free survival
Measured: every 6 months
overall survival
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionFeb 2009
Why it stopped: AOI Pharma terminated the license agreement. IND Transferred to NCI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx / AOI Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Quinn, MD, Study chair, Preston Robert Tisch Brain Tumor Center at Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389090
- Sponsor's protocol ID
- O6BG 202
- Status last verified
- Feb 2012
- First submitted
- 16 Oct 2006
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
- ClinicalTrials.gov ID
- NCT00389090
- Acronym / sponsor ID
- O6BG 202
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma, Oligoastrocytoma
- Keywords
- temozolomide resistant, anaplastic glioma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AOI Pharma terminated the license agreement. IND Transferred to NCI
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Keryx / AOI Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Oct 2006 (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 an open-label, multicenter, phase II trial, assessing the antitumor activity, and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Detailed description
This open-label, multicenter, phase II trial will assess the antitumor activity and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be enrolled in this study. Total accrual on this study will not exceed 116 patients. The patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning immediately after the first bolus infusion and continuing until immediately prior to the last bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients may receive treatment at the same dose level until appearance of significant treatment-related toxicities, disease progression or withdrawal of consent.
Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for the duration of therapy, using physical and neurological examinations and diagnostic imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide + O6BG | Experimental | Drug: Temozolomide and O6-Benzylguanine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
- Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
- Disease progression >= 12 weeks after the completion of any radiotherapy.
- If patient received chemotherapy or an investigational agent as part of their prior therapy, the patient must recover from all toxicities (<= Grade 1) prior to enrollment on this protocol.
- Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
Key exclusion criteria (8 listed)
- Pregnant or breast feeding women.
- Prior treatment with O6-BG plus temozolomide in combination.
- Active infection requiring intravenous antibiotics.
- Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
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 |
|---|---|---|
| Temozolomide and O6-BenzylguanineAlso: temodarO6BG + Temozolomide | Drug | Temozolomide + O6BG |
Primary outcome
best objective response rate
Time frame: Month 1, 2 and every 2 months thereafter.
3 secondary outcomes
Safety Assessment
Time frame: Month 1, 2 and every 2 months thereafter
progression-free survival
Time frame: every 6 months
overall survival
Time frame: every 6 months
Results and safety
The study was stopped early (reason given: AOI Pharma terminated the license agreement. IND Transferred to NCI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
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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.
Jennifer Quinn, MD study chair
Preston Robert Tisch Brain Tumor Center at Duke
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide and O6-Benzylguanine in people with Glioma and Astrocytoma, run by Keryx / AOI Pharmaceuticals, Inc. at 12 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 15 inclusion and 8 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 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 phase mean?
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?
The study was stopped early (reason given: AOI Pharma terminated the license agreement. IND Transferred to NCI). 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?
best objective response rate (time frame: Month 1, 2 and every 2 months thereafter.). 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 9 Feb 2012.