A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma

Stopped early · Phase 2

Conditions studied: Glioma, Astrocytoma, Oligodendroglioma, Oligoastrocytoma

In brief

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.

Key facts

Study ID

NCT00389090

Run by

Keryx / AOI Pharmaceuticals, Inc.

People needed

32

Starts

2006-10-01

Expected to finish

2009-02-01

Last updated by the study team

2012-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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