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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

Phase 1
3 Years
21 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

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

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI Biopsy
is neither necessary nor encouraged A least two-thirds of the tumor is in the pons Origin
of the tumor is clearly in the pons Must be registered within 28 days of diagnosis
Clinical history less than 6 months duration (cranial nerve deficit, long tract signs, or
ataxia) No diffuse leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life
expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3
Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal:
Creatinine normal for age OR Creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at
stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not
specified Other: No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark L. Greenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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