Clinical Trials Directory

Trials / Completed

CompletedNCT00003304

Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
29 (estimated)
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC · Network
Sex
All
Age
18 Years – 69 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.

Detailed description

OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients. OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
DRUGtemozolomide

Timeline

Start date
1998-04-01
Primary completion
2000-03-01
First posted
2004-08-26
Last updated
2012-03-06

Locations

37 sites across 12 countries: Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Portugal, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT00003304. Inclusion in this directory is not an endorsement.