Trials / Completed
CompletedNCT00020150
Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors
Phase I Trial and Pharmacokinetic Study of Temozolomide and O6-Benzylguanine in Childhood Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of temozolomide administered with a biologically active dose of O6-benzylguanine (O6-BG) in children with refractory solid tumors. * Determine the dose-limiting toxicity and the toxicity profile of this combination in these patients. * Assess the plasma pharmacokinetics of O6-BG and its active metabolite, 8-oxo-O6-BG, in these patients. * Assess the plasma pharmacokinetics of this combination in these patients. * Correlate levels of alanine-glyoxylate aminotransferase in peripheral blood mononuclear cells with the degree of hematologic toxicity of this combination in these patients. OUTLINE: This is a dose-escalation study. Patients receive O6-benzylguanine (O6-BG) IV over 1 hour followed 30 minutes later by oral temozolomide daily for 5 days. Treatment continues every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression. Sequential dose escalation of O6-BG is followed by sequential dose escalation of temozolomide. Cohorts of 3-6 patients receive escalating doses of O6-BG and temozolomide until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity. Quality of life is assessed at baseline and prior to courses 1, 3, 6, 8, and 12. PROJECTED ACCRUAL: A total of 21-48 patients will be accrued for this study within 1-2 years.
Conditions
- Brain and Central Nervous System Tumors
- Childhood Germ Cell Tumor
- Extragonadal Germ Cell Tumor
- Kidney Cancer
- Liver Cancer
- Neuroblastoma
- Ovarian Cancer
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | O6-benzylguanine | |
| DRUG | temozolomide |
Timeline
- Start date
- 2000-06-01
- First posted
- 2003-01-27
- Last updated
- 2015-04-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00020150. Inclusion in this directory is not an endorsement.