Status:
COMPLETED
Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Keryx / AOI Pharmaceuticals, Inc.
National Institutes of Health (NIH)
Conditions:
Glioblastoma Multiforme
Anaplastic Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objectives: To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in patients with Temodar-resistant malignant glioma. To further define toxicity of combo therapy u...
Detailed Description
2 separate strata accrued independently of each other: Stratum 1-patients with Glioblastoma Multiforme (GBM). Stratum 2-patients with Anaplastic Glioma \[anaplastic astrocytoma (AA), anaplastic oligod...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients have recurrent/progressive Malignant Glioma (MG). Stereotactic biopsy at time of recurrence/progression is only required if radiation-induced necrosis is suspected
- Patients have MG resistant to Temodar, which is defined as \> or = to 25 percent increase in tumor growth on contrast enhanced MRI/CT within 8 weeks of last dose of Temodar
- Age \> or = to 18 years
- Evidence of measurable enhancing disease on contrast-enhanced MRI, unless medically contraindicated.
- Interval of at least 2 weeks between prior surgical resection/ 4 weeks between prior radiotherapy/chemotherapy, and enrollment on protocol unless there is unequivocal evidence of tumor progression. However, patients treated with chemotherapy agents such as VP-16 who would normally be retreated after shorter intervals may be treated at usual starting time even if less than 4 weeks from last prior dose of chemotherapy
- Karnofsky performance score \> or = to 60 percent
- Hematocrit \> 29 percent, absolute neutrophil count (ANC) \> 1,500 cells/microliter, platelets \> 100,000 cells/microliter
- Serum creatinine \<1.5 mg/dl, Blood Urea Nitrogen (BUN) \<25 mg/dl, Serum Glutamic Oxaloacetic Transaminase (SGOT) \& bilirubin \<1.5 x upper limit of normal (ULN)
- For patients on corticosteroids, they must have been on stable dose for 1 week prior to entry, if clinically possible, and dose should not be escalated over entry dose level
- Signed informed consent approved by Institutional Review Board (IRB) prior to patient entry
- If sexually active, patients will take contraceptive measures for duration of treatments
- Exclusion criteria:
- Pregnancy
- Co-medication that may interfere with study results
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00613093
Start Date
October 1 2002
End Date
August 1 2008
Last Update
July 9 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710