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

Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006461
• Other study ID #: P9934
• Secondary ID: NCI-2012-02362CD
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2000
• Last updated: August 7, 2013
• Start date: October 2000

Study information

• Verified date: August 2013
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin
Given IV
• cyclophosphamide
Given IV
• vincristine sulfate
Given IV
• etoposide
Given PO

Procedure:
• therapeutic conventional surgery
Undergo surgery

Radiation:
• 3-dimensional conformal radiation therapy
Undergo 3-dimensional conformal radiation therapy

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival rate		1 year	No
Secondary	Acute and chronic toxicities associated with the treatment regimens		Up to 9 years	Yes
Secondary	Neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation		Up to 9 years	No
Secondary	Feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations		Up to 9 years	No
Secondary	Incidence of atypical teratoid and/or rhabdoid tumor		Up to 9 years	No