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Management of Children Aged Less Than 3 Years With Brain Tumors

Phase 2
3 Years
Open (Enrolling)
Brain and Central Nervous System Tumors, Neuroblastoma

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Trial Information

Management of Children Aged Less Than 3 Years With Brain Tumors


- Determine the response rate in children under 36 months of age with primary brain or
brain stem tumors treated with vincristine, methotrexate, carboplatin,
cyclophosphamide, and cisplatin with or without radiotherapy.

- Determine the event-free survival and overall survival in children treated with this

- Determine the pattern of local recurrence or occurrence of CNS metastases in children
treated with this regimen.

- Determine the quality of life in children treated with this regimen.

- Determine the tolerability and long-term toxicity of this regimen in these children.

- Determine the proportion of children who require radiotherapy after treatment with this

- Determine the prognosis of children who receive both chemotherapy and radiotherapy.

- Determine the nature and behavior of brain tumors in very young children.

OUTLINE: This is a multicenter study.

- Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV
over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14;
cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours
on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients
who achieve a complete response proceed to observation, as do those achieving a partial
response with no tumor present on biopsy. Patients with biopsy proven residual tumors
after 12 months of chemotherapy or recurrent tumors that don't have the potential to
spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients
with unresponsive disease or progressive disease that has the potential to spread
through the CSF proceed to craniospinal radiotherapy.

- Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.

- Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for
4 weeks.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for at least 2

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of 1 of the following:

- Brain stem tumor (histological confirmation not required)

- Histologically confirmed primary intracranial brain tumor of 1 of the following

- Anaplastic (malignant) astrocytoma

- Glioblastoma

- Anaplastic (malignant) oligodendroglioma

- Ependymoma

- Anaplastic (malignant) ependymoma

- Anaplastic (malignant) oligoastrocytoma

- Choroid plexus carcinoma

- Astroblastoma

- Polar spongioblastoma

- Gliomatosis cerebri

- Anaplastic (malignant) ganglioglioma

- Pineoblastoma

- Mixed pineocytoma or pineoblastoma

- Medulloepithelioma

- Neuroblastoma

- Ependymoblastoma

- Primitive neuroectodermal tumors (PNETs), including medulloblastoma or
cerebral or spinal PNETs

- Has undergone surgery or biopsy of the tumor within the past 2-4 weeks


- No concurrent unrelated disease, including hematological or renal disease, that would
preclude study treatment


- No prior chemotherapy or radiotherapy

- Prior steroids allowed

- No concurrent steroids as anti-emetics

- Concurrent steroids allowed for control of tumor-related symptoms

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Richard Grundy, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Queen's Medical Centre


United States: Federal Government

Study ID:




Start Date:

June 1992

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • untreated childhood brain stem glioma
  • childhood high-grade cerebral astrocytoma
  • childhood low-grade cerebral astrocytoma
  • untreated childhood cerebellar astrocytoma
  • childhood choroid plexus tumor
  • childhood infratentorial ependymoma
  • childhood supratentorial ependymoma
  • newly diagnosed childhood ependymoma
  • untreated childhood medulloblastoma
  • childhood oligodendroglioma
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • disseminated neuroblastoma
  • localized resectable neuroblastoma
  • localized unresectable neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms