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Temodar and O6-Benzylguanine · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Patients with glioblastoma multiforme | ACTIVE_COMPARATOR | - |
| Patients with Anaplastic Glioma | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Schedule 1 |
| 2 | EXPERIMENTAL | Schedule 2 |
| 3 | EXPERIMENTAL | Schedule 2, Neulasta-supported |
| Name | Type | Description |
|---|---|---|
| Temodar and O6-Benzylguanine (BG) | DRUG | Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG). BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle. |
| Temodar and O6-Benzylguanine | DRUG | O6-BG 120mg/m2 administered intravenously over 1 hr followed by continuous infusion of O6-BG at 30 mg/m2/day for 5 consecutive days. Every 48 hrs repeat dose of 120 mg/m2 over 1 hr administered for total of 3 doses. Temodar administered orally, in fasting state within 60 minutes of end of 1st 1-hr infusion of O6-BG \& then every 24 hrs during continuous infusion of O6-BG. Temodar administered on day 1 of treatment cycle \& every 24 hrs thereafter for 5 days with treatment cycles repeated every 28 days. Pts must fast for minimum of 1 hr prior to administration of each dose of Temodar \& continue fasting 2 hrs after administration of each Temodar dose. |
| Temodar, O6-BG, and Irinotecan | DRUG | 2 separate strata accrued independently: Stratum 1-pts receiving Dilantin, Tegretol or phenobarbital. Stratum 2-pts on anti-convulsants other than Dilantin, Tegretol/phenobarbital/pts not on any anti-convulsants. O6-BG administered intravenously 120mg/m2, over 1hr, prior to administration of Temozolomide on day 1 of 21day cycle. O6-BG administered intravenously 30mg/m2/day, over 48hrs, immediately after completion of CPT-11 infusion on day 1 of 21-day cycle. Temozolomide administered orally 355mg/m2 within 60 mins of end of 1hr O6-BG infusion. Treatment cycles may be repeated every 3wks following dose of Temozolomide from previous cycle. CPT-11 administered intravenously in fasting state over 90mins. CPT-11 infusion will begin 1hr after Temozolomide administration. Initial doses 60mg/m2 for stratum 1 \& 40mg/m2 for stratum2. Treatment cycles repeated every 3 wks following dose of CPT-11 from previous cycle. |
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 gro...
Temodar and O6-Benzylguanine is an investigational combination being studied for the treatment of glioblastoma and glioblastoma multiforme, which are aggressive brain cancers. It is also being evaluated in related conditions such as gliosarcoma and anaplastic glioma. The combination is in clinical development for patients with recurrent or progressive disease.
Temodar and O6-Benzylguanine is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company is conducting clinical trials to evaluate this combination therapy in patients with brain tumors.
Temodar and O6-Benzylguanine is in Phase 1 clinical development. The combination has completed two Phase 1 trials and one Phase 2 trial, all of which are finished. It remains an investigational therapy and is not yet approved by regulatory authorities.
Temodar and O6-Benzylguanine has been studied in three completed clinical trials. NCT00612638 evaluated the combination with irinotecan in recurrent or progressive cerebral anaplastic gliomas. NCT00612989 tested a 5-day regimen in recurrent or progressive glioblastoma. NCT00613093 assessed the combination in temozolomide-resistant malignant glioma.
Temodar and O6-Benzylguanine is a combination therapy that includes temozolomide, which is the active ingredient in the brand-name drug Temodar. The combination adds O6-benzylguanine, an agent designed to enhance the effectiveness of temozolomide. This combination is being studied specifically for brain tumors.