Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	8 months to 3 years	NCI	COG-P9934 POG-P9934, NCT00006461, P9934

Objectives

1. Compare the efficacy of cyclophosphamide, vincristine, cisplatin, and etoposide followed by second-look surgery and focal conformal radiotherapy vs combination therapy administered on POG 9233 in terms of event-free survival rates in children with nonmetastatic medulloblastoma or posterior fossa primitive neuroectodermal tumor.
2. Assess the feasibility and safety of this treatment regimen in these patients.
3. Determine the acute and chronic toxicities of this regimen in these patients.
4. Determine the neuropsychological and neuroendocrine effects of this regimen in these patients.
5. Determine the incidence of atypical teratoid/rhabdoid tumor in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor
  • Prior definitive tumor resection within 6 weeks of study



• No evidence of metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 8 months to 3 years

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 10 g/dL
• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• AST less than 2.5 times normal
• Bilirubin less than 1.5 mg/dL

Renal:

• Creatinine less than 1.2 mg/dL

  OR

• Creatinine clearance greater than 70 mL/min

Expected Enrollment

A total of 65 patients will be accrued for this study.

Outcomes

Event-free survival rate at 1 year

Feasibility and safety
Toxicity
Neuropsychological and neuroendocrine effects
Incidence of atypical teratoid and/or rhabdoid tumor

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

David Ashley, MBBS, FRACP, PhD, Protocol chair		Ph: 61-3-9345-5522

Registry Information
Official Title		Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children Greater Than or Equal to 8 months and Less Than 3 years with Non-metastatic Medulloblastoma: A Children's Oncology Group Phase III Study
Trial Start Date		2000-10-13
Trial Completion Date		2009-01-26
Registered in ClinicalTrials.gov		NCT00006461 1
Date Submitted to PDQ		2000-08-29
Information Last Verified		2006-06-21
NCI Grant/Contract Number		CA30969

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00006461