Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.


Clinical Trial Description

OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma. II. Assess the toxicity of this regimen in this patient population.

OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00003935
Study type Interventional
Source Children's Oncology Group
Contact
Status Completed
Phase Phase 1
Start date September 1999
Completion date March 2007

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Completed NCT02537106 - A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation N/A
Completed NCT01951950 - Nicardipine vs Esmolol Craniotomy Emergence Phase 1
Completed NCT01222780 - To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer Phase 1
Completed NCT00873184 - Study of Massage Therapy Within a Brain Tumor Setting N/A
Active, not recruiting NCT01115777 - Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
Completed NCT00724191 - Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
Recruiting NCT04128306 - Brain Areas of Time-To-Contact Perception: an Awake Surgery Study N/A
Recruiting NCT05202899 - Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy Phase 4
Completed NCT00707343 - [F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors Phase 1
Completed NCT00850278 - Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors N/A
Completed NCT00528437 - Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors Phase 2
Terminated NCT00107471 - Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma Phase 1/Phase 2
Completed NCT00187174 - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors Phase 1
Completed NCT00135876 - Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients Phase 3
Completed NCT00062478 - Study of Karenitecin (BNP1350) in Patients With Brain Tumors Phase 2
Completed NCT00241670 - Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid Phase 3
Not yet recruiting NCT01445691 - More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery Phase 2
Terminated NCT01018290 - Navigated Transcranial Magnetic Stimulation in Tumor Surgery N/A
Completed NCT00003573 - Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma Phase 2