International Randomized Phase II Trial of the Combination of Vincristine and Irinotecan With or Without Temozolomide (VI or VIT) in Children and Adults With Refractory or Relapsed Rhabdomyosarcoma
The dose of vincristine will be 1.5 mg/m² or 0.05 mg/kg for patient ≤ 10 kg (maximum 2 mg)
and will be administered by direct intravenous infusion on day 1 and 8 of each course,
The dose of irinotecan will be 50 mg/m²/d. Irinotecan will be given intravenously over 1
hour on days 1-5 of each course, one hour following the administration of temozolomide.
In the absence of any contraindication (ie known allergies), treatment with oral cefixime 8
mg/kg once daily (maximum daily dose 400 mg) is recommended and will be started 2 days
before chemotherapy until day 7.
Temozolomide will be given according to the randomization. The starting dose of temozolomide
will be 125 mg/m²/d. The dose of temozolomide will be escalated to 150 mg/m²/day at cycle 2
for patients who do not experience > grade 3 toxicity of any kind. Temozolomide will be
given orally, on an empty stomach, on days 1 through 5 of each course.
Dose reductions and/or administration delays will be performed using specific predefined
rules to accommodate individual patient tolerance of treatment and to maintain optimal dose
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumour response and progression in each treatment arm.
The primary efficacy endpoint is defined as the proportion of patients who had a documented complete or partial tumour response occurring after the first 2 cycles of treatment which must be confirmed by a follow-up objective tumour assessment obtained within 4-5 weeks after the initial documentation.
at least 6 weeks (two cycles of treatment)
Anne-Sophie DEFACHELLES, MD, International coordinator
Centre Ocsar Lambet, Lille, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)