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Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation


Phase 2
10 Years
65 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation


OBJECTIVES:

- Determine the toxicity of adjuvant dose-intensive induction chemotherapy with
cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate
followed by standard radiotherapy in patients with surgically resected, newly diagnosed
high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or
incompletely resected ependymoma.

- Determine the response rate, time to progression, overall survival, and pattern of
failure in these patients treated with this regimen.

OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV
over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and
cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence
of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day
3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and
continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total
of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then
undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of
chemotherapy.

Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1
year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histological confirmation of one of the following:

- High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or
greater)

- Primitive neuroectodermal tumor

- Ependymoma

- Incompletely resected on postoperative MRI or neurosurgical report

- Definitive prior surgery within 42 days of study

PATIENT CHARACTERISTICS:

Age:

- 10 to 65

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 1.5 mg/dL

- SGPT less than 2.5 times upper limit of normal

Renal:

- Creatinine clearance greater than 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed

- No concurrent corticosteroids as antiemetics

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jonathan L. Finlay, MB, ChB

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Federal Government

Study ID:

CDR0000068192

NCT ID:

NCT00006258

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood infratentorial ependymoma
  • childhood supratentorial ependymoma
  • adult medulloblastoma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • adult ependymoblastoma
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood medulloblastoma
  • newly diagnosed childhood ependymoma
  • adult supratentorial primitive neuroectodermal tumor (PNET)
  • Ependymoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

Location

Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Children's Hospital Los AngelesLos Angeles, California  90027-0700