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

NCT ID: NCT00003015

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Brief Summary

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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.

Detailed Description

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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.

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.

Conditions

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Brain and Central Nervous System Tumors

Keywords

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childhood low-grade cerebral astrocytoma childhood oligodendroglioma untreated childhood visual pathway glioma untreated childhood cerebellar astrocytoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

conventional surgery

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Societe Internationale d'Oncologie Pediatrique

OTHER

Sponsor Role lead

Principal Investigators

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David A. Walker

Role: STUDY_CHAIR

Queen's Medical Center

Locations

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Zentralklinikum Augsburg

Augsburg, , Germany

Site Status

University of Padua

Padua, , Italy

Site Status

Queen's Medical Centre

Nottingham, England, United Kingdom

Site Status

Countries

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Germany Italy United Kingdom

References

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Gnekow AK, Perilongo G, Zanetti I, et al.: Single dose carboplatin and vincristine (VER) for progressive low-grade glioma (LGG) in childhood. A SIOP/GPOH study. [Abstract] International Symposium on Pediatric Neuro-Oncology, May 18-21, 1994, Houston, Tx. A-89, 1999.

Reference Type RESULT

Other Identifiers

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SIOP-95-2

Identifier Type: -

Identifier Source: secondary_id

EU-96063

Identifier Type: -

Identifier Source: secondary_id

CDR0000065595

Identifier Type: -

Identifier Source: org_study_id