Back to Search
Start Over
Phase I study of temozolomide in children and adolescents with recurrent solid tumors: a report from the Children's Cancer Group.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 1998 Sep; Vol. 16 (9), pp. 3037-43. - Publication Year :
- 1998
-
Abstract
- Purpose: The Children's Cancer Group conducted a phase I trial of temozolomide stratified by prior craniospinal irradiation (CSI).<br />Patients and Methods: Children and adolescents with recurrent or progressive cancer were enrolled. Temozolomide was administered orally daily for 5 days, with subsequent courses administered every 21 to 28 days after full hematologic recovery. Dose levels tested included 100, 150, 180, 215, 245, and 260 mg/m2 daily.<br />Results: Twenty-seven patients on the non-CSI stratum were assessable for hematologic toxicity. During the first three dose levels (100, 150, and 180 mg/m2 daily), only grades 1 and 2 hematologic toxicity occurred. One patient at 215 mg/m2 daily had grade 3 hematologic toxicity. Three of eight patients (38%) treated at 245 to 260 mg/m2 daily had dose-limiting toxicity (DLT), which included both neutropenia and thrombocytopenia. Twenty-two patients on the CSI stratum were assessable for hematologic toxicity. Hematologic DLT occurred in one of six patients (17%) at 100 mg/m2 daily and in two of four patients (50%) at 215 mg/m2 daily. No nonhematologic DLT occurred; nausea and vomiting occurred in more than half of the patients. After two courses of temozolomide, 10 patients had stable disease (SD), and three patients had a partial response (PR), one of whom subsequently had a complete response (CR) that persists through 24 months of follow-up.<br />Conclusion: The maximum-tolerated dose (MTD) of temozolomide for children and adolescents without prior CSI is 215 mg/m2 daily and for those with prior CSI is 180 mg/m2 daily for 5 days, with subsequent courses that begin on day 28. Temozolomide is well tolerated and should undergo phase II testing in children and adolescents.
- Subjects :
- Adolescent
Adult
Antineoplastic Agents, Alkylating adverse effects
Child
Child, Preschool
Dacarbazine adverse effects
Dacarbazine therapeutic use
Dose-Response Relationship, Drug
Female
Humans
Male
Temozolomide
Antineoplastic Agents, Alkylating therapeutic use
Dacarbazine analogs & derivatives
Neoplasm Recurrence, Local drug therapy
Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 16
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 9738573
- Full Text :
- https://doi.org/10.1200/JCO.1998.16.9.3037