Clinical trial · Interventional
Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma
Phase II Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma
NCT00613093CI-TRIAL-00015039completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Glioma | WHO Grade 3 Glioma | ALIAS | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temodar and O6-Benzylguanine (BG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients with glioblastoma multiforme
- interventionNames
- Drug: Temodar and O6-Benzylguanine (BG)
- type
- ACTIVE_COMPARATOR
- label
- Patients with Anaplastic Glioma
- interventionNames
- Drug: Temodar and O6-Benzylguanine (BG)
Primary outcomes (1)
- measure
- Radiographic evidence of tumor response
- timeFrame
- 6 months
Secondary outcomes (2)
- measure
- 6 month progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.