RHABDOMYOSARCOMA Clinical Trial
Official title:
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
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.
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, before
irinotecan.
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
intensity.
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