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Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years

Primary Purpose

Metastatic, Cerebral Primitive Neuroectodermal Tumors

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Chemotherapy (carboplatin, etoposide, thiotepa)
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic, Cerebral Primitive Neuroectodermal Tumors

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Type of tumor:

    • Metastatic medulloblastoma whatever the quality of the initial resection (radiologically visible metastases by MRI and/or CSF invaded by at least one mass of tumoral cells).
    • Incompletely resected local medulloblastoma with a residue > 1.5 cm2.
    • Anaplastic, large cell medulloblastoma whatever the risk criteria (localized or metastatic, complete or incomplete resection).
    • Medulloblastoma with amplification of c-myc or N-myc whatever the risk criteria (local or metastatic, complete or incomplete resection).
    • Local and/or metastatic sustentorial PNET.
  2. Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years.
  3. Age at diagnosis of S-PNET of more than 10 years and less than 20 years.
  4. Nutritional and general status compatible with treatment, Lansky score > 60.
  5. Estimated life expectancy > 1 months.
  6. Radiographs must be available for the second reading in dicom format on a CD-ROM.
  7. Hematological function at diagnosis: PMN > 1.0 x 109/l and platelets > 100 x 109/l.
  8. Hepatic function at diagnosis: serum bilirubin < 1.5 times normal value; ASAT and ALAT < 2.5 times normal values; prothrombin time > 50%; fibrinogen > 1.5 g/l.
  9. Renal function at diagnosis: serum creatinine according to age in a correctly hydrated child: 1 to 15 years < 65 micromol/l; 15 to 18 years < 110 micromol/l.
  10. No organ toxicity (Grade > 2 according to NCI-CTC coding, version 2.0)
  11. No other concomitant anti-cancer treatment.
  12. No prior anti-cancer therapy.
  13. No prior irradiation.
  14. Written informed consent signed by both parents or legal guardians

Exclusion Criteria:

  1. Failure to comply with one of the inclusion criteria.
  2. Severe or life-threatening infection.
  3. Uncontrolled active or symptomatic intracranial hypertension.
  4. Refusal of parents or legal guardian.
  5. Patients incapable of undergoing medical follow-up for geographical, social or mental reasons

Sites / Locations

  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm Description

Conventional chemotherapy: carboplatin injection (160 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Etoposide injection (100 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Double intensification by high-dose chemotherapy followed by autologous PBSC rescue: thiotepa injection (200 mg/m²/day as an infusion over one hour in 200 ml/m² of 5 % GS) administered from D42 to D44 and from D63 to D65. Autologous PBSC rescue on D47 and D68. Surgical resection of any tumor residue. Irradiation of the primary tumor site and cerebrospinal axis: 54 Gy to primary tumor, 36 Gy to cerebrospinal axis. Maintenance treatment: Temozolomide 150 mg/m²/day orally for 5 days every 28 days, from 1 month after the end of irradiation. 6 cycles planned. Duration of treatment: 13 months

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
June 25, 2020
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00936156
Brief Title
Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary
Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic, Cerebral Primitive Neuroectodermal Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Conventional chemotherapy: carboplatin injection (160 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Etoposide injection (100 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Double intensification by high-dose chemotherapy followed by autologous PBSC rescue: thiotepa injection (200 mg/m²/day as an infusion over one hour in 200 ml/m² of 5 % GS) administered from D42 to D44 and from D63 to D65. Autologous PBSC rescue on D47 and D68. Surgical resection of any tumor residue. Irradiation of the primary tumor site and cerebrospinal axis: 54 Gy to primary tumor, 36 Gy to cerebrospinal axis. Maintenance treatment: Temozolomide 150 mg/m²/day orally for 5 days every 28 days, from 1 month after the end of irradiation. 6 cycles planned. Duration of treatment: 13 months
Intervention Type
Drug
Intervention Name(s)
Chemotherapy (carboplatin, etoposide, thiotepa)
Intervention Description
Conventional chemotherapy: carboplatin injection (160 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Etoposide injection (100 mg/m²/day by infusion over one hour in 5 % glucose saline) administered from D1 to D5 and from D22 to D26. Double intensification by high-dose chemotherapy followed by autologous PBSC rescue: thiotepa injection (200 mg/m²/day as an infusion over one hour in 200 ml/m² of 5 % GS) administered from D42 to D44 and from D63 to D65. Autologous PBSC rescue on D47 and D68. Surgical resection of any tumor residue. Irradiation of the primary tumor site and cerebrospinal axis: 54 Gy to primary tumor, 36 Gy to cerebrospinal axis. Maintenance treatment: Temozolomide 150 mg/m²/day orally for 5 days every 28 days, from 1 month after the end of irradiation. 6 cycles planned. Duration of treatment: 13 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type of tumor: Metastatic medulloblastoma whatever the quality of the initial resection (radiologically visible metastases by MRI and/or CSF invaded by at least one mass of tumoral cells). Incompletely resected local medulloblastoma with a residue > 1.5 cm2. Anaplastic, large cell medulloblastoma whatever the risk criteria (localized or metastatic, complete or incomplete resection). Medulloblastoma with amplification of c-myc or N-myc whatever the risk criteria (local or metastatic, complete or incomplete resection). Local and/or metastatic sustentorial PNET. Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years. Age at diagnosis of S-PNET of more than 10 years and less than 20 years. Nutritional and general status compatible with treatment, Lansky score > 60. Estimated life expectancy > 1 months. Radiographs must be available for the second reading in dicom format on a CD-ROM. Hematological function at diagnosis: PMN > 1.0 x 109/l and platelets > 100 x 109/l. Hepatic function at diagnosis: serum bilirubin < 1.5 times normal value; ASAT and ALAT < 2.5 times normal values; prothrombin time > 50%; fibrinogen > 1.5 g/l. Renal function at diagnosis: serum creatinine according to age in a correctly hydrated child: 1 to 15 years < 65 micromol/l; 15 to 18 years < 110 micromol/l. No organ toxicity (Grade > 2 according to NCI-CTC coding, version 2.0) No other concomitant anti-cancer treatment. No prior anti-cancer therapy. No prior irradiation. Written informed consent signed by both parents or legal guardians Exclusion Criteria: Failure to comply with one of the inclusion criteria. Severe or life-threatening infection. Uncontrolled active or symptomatic intracranial hypertension. Refusal of parents or legal guardian. Patients incapable of undergoing medical follow-up for geographical, social or mental reasons
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.igr.fr/
Description
Related Info

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Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years

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