ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003015
Recruitment Status : Unknown
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 27, 2004
Last Update Posted : December 4, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
May 27, 2004
December 4, 2013
January 1997
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00003015 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade Glioma
Ultimate Low Grade Glioma Study

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.

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.

Interventional
Phase 3
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: carboplatin
  • Drug: vincristine sulfate
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Not Provided
Not Provided
Not Provided

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

Sexes Eligible for Study: All
up to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   United Kingdom
 
 
NCT00003015
CDR0000065595
SIOP-95-2
EU-96063
Not Provided
Not Provided
Not Provided
Not Provided
Societe Internationale d'Oncologie Pediatrique
Not Provided
Study Chair: David A. Walker Queen's Medical Centre
National Cancer Institute (NCI)
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP