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

Sponsor
Centre Oscar Lambret
Study ID
NCT01355445
Phase
PHASE2
Status
Completed

Conditions

  • RHABDOMYOSARCOMA

Eligibility Criteria

Sex
ALL
Age
6 Months - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Vincristine, Irinotecan — DRUG
    * 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
  • Vincristine, Irinotecan, Temozolomide — DRUG
    * 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

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Sep 2019
Primary completion
Jun 30, 2018
Completion
May 31, 2019

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Vincristine / Irinotecan
    Vincristine, Irinotecan Vincristine :1.5 mg/m² (max 2mg), IV Irinotecan : Irinotecan 50 mg/m²/d, IV
  • Experimental: Vincristine / Irinotecan / Temozolomide
    Vincristine, Irinotecan, Temozolomide

Primary Outcome Measure

Objective tumour response and progression in each treatment arm. [ Time Frame: at least 6 weeks (two cycles of treatment) ]

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