A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin

Phase 1 Completed 13 enrolled Children's Hospital Los Angeles

NaSingle-groupOpen-labelTreatment

Summary

This phase I study is designed to determine the maximum tolerated dose of Irinotecan given intravenous for 5 days every 3 weeks in combination with fixed doses of Vincristine, Temozolomide and Bevacizumab (VIT-B) in patients with refractory solid tumors.

Timeline

Start: 2009-09
Primary completion: 2013-02
Completion: 2013-02

Publications

Results Venkatramani R, Malogolowkin M, Davidson TB, May W, Sposto R, Mascarenhas L. A phase I study of vincristine, irinotecan, temozolomide and bevacizumab (vitb) in pediatric patients with relapsed solid tumors. PLoS One. 2013 Jul 22;8(7):e68416. doi: 10.1371/journal.pone.0068416. Print 2013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Irinotecan	Small molecule	20 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	30 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	40 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	50 mg/m2	Intravenous
Subject	Temozolomide	Small molecule	100 mg/m2	Oral
Subject	Vincristine	Small molecule	1.5 mg/m2	Intravenous

A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin

Summary

Timeline

Publications

Drugs

Indications