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

This study is ongoing, but not recruiting participants.

Sponsored by: Societe Internationale d'Oncologie Pediatrique
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003015
  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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: vincristine sulfate
Procedure: conventional surgery
Procedure: radiation therapy
Phase III

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Carboplatin    Vincristine sulfate    Vincristine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Ultimate Low Grade Glioma Study

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   200
Study Start Date:   January 1997

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.

  Eligibility
Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003015

Locations
Germany
Zentralklinikum Augsburg    
      Augsburg, Germany, DOH-8-6156
Italy
University of Padua    
      Padua, Italy, 35128
United Kingdom, England
Queen's Medical Centre    
      Nottingham, England, United Kingdom, NG7 2UH

Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique

Investigators
Study Chair:     David A. Walker     Queen's Medical Centre    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 

Study ID Numbers:   CDR0000065595, SIOP-95-2, EU-96063
First Received:   November 1, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00003015
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood low-grade cerebral astrocytoma  
childhood oligodendroglioma  
untreated childhood visual pathway glioma  
untreated childhood cerebellar astrocytoma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Vincristine
Neuroepithelioma
Oligodendroglioma
Carboplatin
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 16, 2008




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