Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma
Completed · Phase 2
Conditions studied: Glioblastoma Multiforme, Anaplastic Glioma
In brief
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 using Temodar + BG.
Key facts
- Study ID
- NCT00613093
- Run by
- Duke University
- People needed
- 67
- Starts
- 2002-10-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2014-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnancy
- Co-medication that may interfere with study results
Where it is running
- Duke University Health System — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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