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Childhood Injuries |
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Clinical Trial: Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
This study is no longer recruiting patients.
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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
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--
- Patients with or without neurofibromatosis type 1 (NF1) with low grade glioma not previously treated with chemotherapy or radiotherapy
- Tumor types considered are: Low grade astrocytoma (Kernohan grade 1/2); Oligodendroglioma; Mixed oligoastrocytoma Ganglioglioma
- Patients with NF1 and hypothalamic/visual pathway glioma are eligible without biopsy
- All CNS sites are eligible, including biopsy proven low grade spinal tumors and intrinsic brain stem tumors
- No malignant (anaplastic) glioma (Kernohan grade 3/4), glioblastoma multiforme, and ependymal tumors
--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
David Austin Walker, Study Chair, Societe Internationale d'Oncologie Pediatrique
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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
Resources
- Childhood Injuries (Centers for Disease Control and Prevention)

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