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

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ClinicalTrials.gov Identifier: NCT00936156
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.

Condition or disease Intervention/treatment Phase
Metastatic, Cerebral Primitive Neuroectodermal Tumors Drug: Chemotherapy (carboplatin, etoposide, thiotepa) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Chemotherapy
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
Drug: Chemotherapy (carboplatin, etoposide, thiotepa)
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




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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936156


Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

Additional Information:
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00936156     History of Changes
Other Study ID Numbers: PNET HR+ 5
CSET 1329
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Etoposide phosphate
Carboplatin
Etoposide
Thiotepa
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs