Brain Tumors Clinical Trial
Official title:
Vincristine, Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine
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 chemotherapy drug with radiation therapy may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation
therapy in treating patients with newly diagnosed brain stem glioma.
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of
vincristine given as an IV push dose in combination with continuous infusion cyclosporine
and oral etoposide concurrent with and prior to radiotherapy in children with newly
diagnosed primary intrinsic brain stem glioma. II. Determine the incidence and severity of
other toxicities of vincristine in this regimen in these patients. III. Determine a safe and
tolerable dose of vincristine under these conditions to be used in phase II studies. IV.
Seek preliminary evidence of antitumor activity in this setting in these patients.
OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily
for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of
vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and
cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion.
Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity
(DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been
exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6
monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on
day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4
years and then annually thereafter.
PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12
patients per year.
;
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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