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

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006461

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Cyclophosphamide Vincristine Cisplatin Etoposide Etoposide phosphate Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival rate at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Feasibility and safety [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Neuropsychological and neuroendocrine effects [ Designated as safety issue: No ]
Incidence of atypical teratoid and/or rhabdoid tumor [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	October 2000
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Assess the feasibility and safety of this treatment regimen in these patients.
Determine the acute and chronic toxicities of this regimen in these patients.
Determine the neuropsychological and neuroendocrine effects of this regimen in these patients.
Determine the incidence of atypical teratoid/rhabdoid tumor in these patients.

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.

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

Eligibility

Ages Eligible for Study:	up to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006461

Show 139 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

David Ashley, MBBS, FRACP, PhD

Royal Children's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068269, COG-P9934, POG-P9934
Study First Received:	November 6, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006461 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood medulloblastoma

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Cyclophosphamide
Neoplasms by Site
Cisplatin
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Glioma
Alkylating Agents
Etoposide

Nervous System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Nervous System Diseases
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Tubulin Modulators
Myeloablative Agonists
Medulloblastoma
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 09, 2009