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

NCT01355445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-18

No results posted yet for this study

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.

Conditions

  • RHABDOMYOSARCOMA

Interventions

DRUG

Vincristine, Irinotecan

* D1 and D8: Vincristine 1.5 mg/m² (max 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg) * D1 to D5: Irinotecan 50 mg/m²/d, IV 1. cycle / 21 days

DRUG

Vincristine, Irinotecan, Temozolomide

* D1 to D5: Temozolomide 125 mg/m²/d, PO (the dose will be escalated to 150 mg/m²/day at cycle 2 for patients who do not experience \> grade 3 toxicity of any kind) * D1 and D8: Vincristine 1.5 mg/m² (maximum 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg) * D1 to D5: Irinotecan 50 mg/m²/d, IV 1. cycle / 21 days

Sponsors & Collaborators

  • SFCE

    collaborator UNKNOWN

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Anne-Sophie DEFACHELLES, MD · Centre Ocsar Lambret, Lille, France

  • Julia CHISHOLM, MD · Royal Marsden NHS Foundation Trust, Surrey, Uinted Kingdom

  • J.H.M. MD MERKS · Emma Children's Hospital, Amsterdam, The Netherlands

  • Michela CASANOVA, MD · Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy

  • Soledad GALLEGO, MDn · Hospital Materno - Infantil Vall D' Hebron, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-06-30
Completion
2019-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355445 on ClinicalTrials.gov