Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma

Phase 2 Completed 120 enrolled Centre Oscar Lambret SFCE · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma.

Timeline

Start: 2012-01
Primary completion: 2018-06
Completion: 2019-05

Outcome

Missed primary endpoint

paper 95% CI, 0.22 to 1.12; P = .09). PMID 34343032 ↗

Publications

Defachelles AS, Bogart E, Casanova M, Merks JHM, Bisogno G, Calareso G, Gallego Melcon S, Gatz SA, Le Deley MC, McHugh K, Probst A, Rocourt N, van Rijn RR, Wheatley K, Minard-Colin V, Chisholm JC. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Sep 20;39(27):2979-2990. doi: 10.1200/JCO.21.00124. Epub 2021 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temozolomide	Small molecule	150 mg/m2	Oral
Comparator	Irinotecan	Small molecule	50 mg/m2	Intravenous
Comparator	Vincristine	Small molecule	0.05 mg/kg	Intravenous
Comparator	Vincristine	Small molecule	1.5 mg/m2	Intravenous