Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Up to 5 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

13 sites in 1 country.

About this study

Official title: Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma

Conditions

High-risk Medulloblastoma

Being tested

Carboplatin + etoposide, Thiotepa, Cyclophosphamide + Busilvex, Temozolimide + Irinotecan, Etoposide + radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Carboplatin + etoposideDrug

  Carboplatin 160 mg/m^2 Day 1 to day 5, as an intravenous infusion over 1 hour. Dilution in 5 % glucose saline or sodium chloride 9 mg/ml (0.9%).

  Etoposide 100 mg/m^2 D ay 1 to day 5, as an intravenous infusion over 1 hour. Dilution in physiological saline or 5 % glucose saline while not exceeding a concentration of 0.4 mg/ml etoposide in the infusion bottle.

• ThiotepaDrug

  Thiotepa 200 mg/m² Day-3 to day-1, as an intravenously infusion over 1 hour dilution in 200 ml/m^2 of 5% glucose saline or sodium chloride 9 mg/ml (0.9%).

• Cyclophosphamide + BusilvexDrug

  Cyclophosphamide:

  • Level 1 20 mg/kg/day
  • Level 2 30 mg/kg/day
  • Level 3 40 mg/kg/day
  • Level 4 50 mg/kg/day

  Busilvex:

  < 9 kgs 0.8 mg/kg/dose -> 3.2 mg/kg/day; 9 à < 16 kgs 0.96 mg/kg/dose -> 3.84 mg/kg/day; 16 à 23 kgs 0.88 mg/kg/dose -> 3.52 mg/kg/day; > 23 à 34 kgs 0.76 mg/kg/dose -> 3.04 mg/kg/day; > 34 kgs -> 0.64 mg/kg/dose.

• Temozolimide + IrinotecanDrug

  During 2 cycles of 21 days:

  • Temozolomide: 100 mg/m^2/day PO from Day 1 to Day 5;
  • Irinotecan: 10 mg/m^2/day IV from Day 1 to Day 5 + from Day 8 to Day 12

• Etoposide + radiotherapyCombination product

  • Etoposide: 35 mg/m^2/day PO during 21days
  • Radiotherapy: 1.8 Gy/fraction/day (total dose: 54 Gy)

• TemozolomideDrug

  150 mg/m^2/day PO during 5 days, during 6 cycles of 21 days

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Phase I - Maximum Tolerated Dose

   To determine the Maximum Tolerated Dose (MTD) of cyclophosphamide in combination with a fixed dose of Busilvex in children with high-risk medulloblastoma who are in complete response after the intensification phase.

   Measured: From inclusion to the Dose Limiting Toxicity up to 12 months

2. Phase II - Event Free Survival

   To assess the efficacy in terms of Event Free Survival (EFS) of the strategy intended to treat children younger than 5 years of age suffering from high-risk medulloblastoma with sequential high-dose chemotherapy without radiotherapy.

   Measured: From inclusion to Event up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 Jan 2014 (estimated)
2. Study start14 Sep 2013
3. Primary completion25 Oct 2020
4. Study completion25 Oct 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for High-risk MedulloblastomaStudies of the same condition, open and under way.
• More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.