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Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study


Phase 3
N/A
3 Years
Not Enrolling
Both
Untreated Childhood Medulloblastoma, Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

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Trial Information

Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study


PRIMARY OBJECTIVES:

I. To determine if the proposed treatment for children >= 8.0 months and < 3 years of age at
registration with non-metastatic (M0) medulloblastoma is more effective than the combined
treatments given to children of the same age and extent of disease on POG 9233, as measured
by event-free survival (EFS) rates.

SECONDARY OBJECTIVES:

I. To assess the feasibility and safety of the planned use of second look surgery and focal
conformal radiation therapy following chemotherapy. II. To determine the acute and chronic
toxicities associated with the above treatment regimens.

III. To describe the neuropsychological and neuroendocrine effects of this systemic
chemotherapy, surgery, and local, conformal radiation. IV. To determine the feasibility and
validity of a centralized telephone interview based data collection method for
neuropsychological evaluations. V. To determine the incidence of atypical teratoid/rhabdoid
tumor (AT/RT) in children enrolled on this study.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy consisting of vincristine IV on days 1, 8, and 15;
cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral
etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses.
After completion of induction chemotherapy, patients with residual disease undergo a second
resection. Within 4 weeks after completion of induction chemotherapy or second resection,
patients receive focal conformal radiotherapy daily, 5 days a week, for 6 weeks. Four weeks
after completion of radiotherapy, patients receive alternating treatments of maintenance
chemotherapy. Patients receive vincristine IV on days 1, 8, and 15 and cyclophosphamide IV
over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of
courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses. Patients are
followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year,
and then annually thereafter.


Inclusion Criteria:



- Histologically confirmed primary medulloblastoma or posterior fossa primitive
neuroectodermal tumor

- Prior definitive tumor resection within 6 weeks of study

- No evidence of metastases

- Hemoglobin at least 10 g/dL

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- AST less than 2.5 times normal

- Bilirubin less than 1.5 mg/dL

- Creatinine less than 1.2 mg/dL

- Creatinine clearance greater than 70 mL/min

- No prior chemotherapy

- No prior radiotherapy

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival rate

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

David Ashley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

P9934

NCT ID:

NCT00006461

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Untreated Childhood Medulloblastoma
  • Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Medulloblastoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

Location

Children's Oncology GroupArcadia, California  91006-3776