drugset / Trial / NCT00020150
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
Treatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating children who have solid tumors that have not responded to previous therapy.
Timeline
- Start
- 2000-06
- Primary completion
- —
- Completion
- —
Publications
- Results Meany HJ, Warren KE, Fox E, Cole DE, Aikin AA, Balis FM. Pharmacokinetics of temozolomide administered in combination with O6-benzylguanine in children and adolescents with refractory solid tumors. Cancer Chemother Pharmacol. 2009 Dec;65(1):137-42. doi: 10.1007/s00280-009-1015-8. Epub 2009 May 9.
- Results Warren KE, Aikin AA, Libucha M, Widemann BC, Fox E, Packer RJ, Balis FM. Phase I study of O6-benzylguanine and temozolomide administered daily for 5 days to pediatric patients with solid tumors. J Clin Oncol. 2005 Oct 20;23(30):7646-53. doi: 10.1200/JCO.2005.02.0024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | O6-benzylguanine | Small molecule | 60 mg/m2 | Intravenous |
| Subject | O6-benzylguanine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | O6-benzylguanine | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 28 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 40 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 55 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 75 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |