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Status unknownNCT00003015Updated Dec 4, 2013

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

A Phase 3 interventional study of carboplatin and vincristine sulfate in Brain and Central Nervous System Tumors, sponsored by Societe Internationale d'Oncologie Pediatrique. Status unknown at 3 sites in 3 countries. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2013-12-04.

Sponsored by Societe Internationale d'Oncologie Pediatrique · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Ages
Up to 15 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

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

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's planned enrollment of 200 is above the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Societe Internationale d'Oncologie Pediatrique is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

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

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Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
200 participants (estimated)

Interventions

  • Drugcarboplatin
  • Drugvincristine sulfate
  • Procedureconventional surgery
  • Radiationradiation therapy
06

Study locations

3 sites
  • Zentralklinikum Augsburg
    Augsburg, DOH-8-6156, Germany
  • University of Padua
    Padua, 35128, Italy
  • Queen's Medical Centre
    Nottingham, England NG7 2UH, United Kingdom
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References and documents

Publications

  • 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00003015
Lead sponsor
Societe Internationale d'Oncologie Pediatrique
First posted
May 27, 2004
Start date
Jan 1997
Last update
Dec 4, 2013

Study contacts

David A. Walker
study chair · Queen's Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2001. You cannot join it, but the record below documents what was studied.

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