Status:
TERMINATED
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
Lead Sponsor:
Keryx / AOI Pharmaceuticals, Inc.
Conditions:
Glioma
Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
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-o...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00389090
Start Date
October 1 2006
End Date
February 1 2009
Last Update
February 9 2012
Active Locations (12)
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1
AOI Pharmaceuticals Investigative Site
Los Angeles, California, United States, 90033
2
AOI Pharmaceuticals Investigative Site
Orlando, Florida, United States, 32804
3
AOI Pharmaceuticals Investigative Site
Chicago, Illinois, United States, 60611
4
AOI Pharmaceuticals Investigative Site
Evanston, Illinois, United States, 60201