A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
NCT ID: NCT00389090
Last Updated: 2012-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
32 participants
INTERVENTIONAL
2006-10-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma
NCT00613093
Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
NCT00612989
O(6)-Benzylguanine and Temozolomide in Treating Patients With Glioblastoma Multiforme That Did Not Respond to Previous Temozolomide and Radiation Therapy
NCT00436436
Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas
NCT00612638
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
NCT00498927
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Temozolomide + O6BG
Temozolomide and O6-Benzylguanine
O6BG + Temozolomide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Temozolomide and O6-Benzylguanine
O6BG + Temozolomide
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
3. Disease progression \>= 12 weeks after the completion of any radiotherapy.
4. 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.
5. Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
6. If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
7. KPS \>= 70%.
8. 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
9. Signed informed consent approved by Institutional Review Board.
10. If sexually active, patients will take contraceptive measures for the duration of the treatment.
11. 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.
Exclusion Criteria
2. Prior treatment with O6-BG plus temozolomide in combination.
3. Active infection requiring intravenous antibiotics.
4. Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
5. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
6. Patients unwilling or unable to comply with the protocol.
7. Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
8. Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Keryx / AOI Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Quinn, MD
Role: STUDY_CHAIR
Preston Robert Tisch Brain Tumor Center at Duke
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AOI Pharmaceuticals Investigative Site
Los Angeles, California, United States
AOI Pharmaceuticals Investigative Site
Orlando, Florida, United States
AOI Pharmaceuticals Investigative Site
Chicago, Illinois, United States
AOI Pharmaceuticals Investigative Site
Evanston, Illinois, United States
AOI Pharmaceuticals Investigative Site
Lexington, Kentucky, United States
AOI Pharmaceuticals Investigative Site
Louisville, Kentucky, United States
AOI Pharmaceuticals Investigative Site
Minneapolis, Minnesota, United States
AOI Pharmaceuticals Investigative Site
Durham, North Carolina, United States
AOI Pharmaceuticals Investigative Site
Greenville, South Carolina, United States
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States
AOI Pharmaceuticals Investigative Site
Houston, Texas, United States
AOI Pharmaceuticals Investigative Site
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
O6BG 202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.