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Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma - Article


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Childhood Injuries




Clinical Trial: Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma

This study is no longer recruiting patients.

Sponsored by: Societe Internationale d'Oncologie Pediatrique
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus vincristine in treating children and adolescents with low grade glioma.

Condition Treatment or Intervention Phase
untreated childhood visual pathway glioma
low-grade childhood cerebral astrocytoma
untreated childhood cerebellar astrocytoma
Childhood Oligodendroglioma
 Drug: carboplatin
 Drug: vincristine
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Study of Carboplatin and Vincristine in Pediatric and Adolescent Patients With Low Grade Glioma

Further Study Details: 

Study start: January 1997

OBJECTIVES: I. Develop a standardized scheme of therapy for children and adolescents with low grade glioma. II. Determine the effectiveness of carboplatin and vincristine in treating children aged less than 5 years with severe or progressive symptoms or unequivocal imaging evidence of tumor growth.

PROTOCOL OUTLINE: A complete resection of tumor is performed on patients with low grade glioma with or without neurofibromatosis type 1. Surgery is reconsidered following tumor relapse, progression, or clinical deterioration. Every effort is made to obtain a biopsy from patients not receiving debulking surgery. Nonoperative patients and postoperative patients who are not candidates for second surgery receive chemotherapy or radiotherapy. Postoperative patients receive radiotherapy following surgical wound healing and within 28 days of resection. Children less than 5 years old receive chemotherapy first, then radiotherapy if the tumor subsequently progresses or recurs. All other patients receive radiotherapy, then chemotherapy. The latter treatment is conducted in the presence of tumor progression. Chemotherapy is given in 2 parts, first an initial intensive phase (phase 1), then a later continuation phase (phase 2). In phase 1, patients receive vincristine IV weekly for 10 weeks and carboplatin IV every 3 weeks. In phase 2, patients receive vincristine IV and carboplatin IV every 4 weeks for a total treatment time of 52 weeks. Chemotherapy continues until disease progression or unacceptable toxicity. Patients receive radiotherapy daily 5 times a week. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study over 5 years.

Eligibility

Ages Eligible for Study:  up to  15 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: See Disease Characteristics
  • Endocrine therapy: Not specified
  • Radiotherapy: See Disease Characteristics
  • Surgery: Not specified

--Patient Characteristics--

  • Age: Under 16
  • Performance status: Not specified
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Not specified
  • Renal: Not specified

Location Information


Germany
      Zentralklinikum Augsburg, Augsburg,  DOH-8-6156,  Germany

Italy
      University of Padua, Padua,  35128,  Italy

United Kingdom, England
      Queen's Medical Centre, Nottingham,  England,  NG7 2UH,  United Kingdom

Study chairs or principal investigators

David Austin Walker,  Study Chair,  Societe Internationale d'Oncologie Pediatrique   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065595; SIOP-95-2; EU-96063
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003015
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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December 4, 2008



Page Updated: November 22, 2004
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