Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Primary Objective:
- Determine the interindividual range and median of individual maximum tolerated doses of
valproic acid administered as one time evening dose in conjunction with a dose oral
etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four
different age groups.
Secondary Objectives:
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of
valproic acid in conjunction with oral etoposide,
- To investigate the clinical pharmacokinetics of valproic acid when given in conjunction
with oral etoposide,
- To describe quality of life of patients with relapsed, or progressive central and
peripheral nervous system tumors when treated with oral valproic acid and etoposide,
- To observe and describe the response pattern of progressive central nervous system
tumors treated with oral valproic acid and etoposide,
- To observe and describe event free survival time and overall survival time of patients
with relapsed, or progressive central nervous system tumors when treated with oral
valproic acid and etoposide,
- To determine if histone deacetylase activity and topoisomerase expression in lymphocytes
of patients is related to valproic acid levels, and
- To determine, if the individual maximal tolerated dose (iMTD) depends on the initial
performance status of the patient in the beginning of the treatment.