drugset / Trial / NCT00500890

Treatment of Tumors of the Choroid Plexus Epithelium

NCT00500890 ↗

Phase 3 Terminated 2 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to compare carboplatin to cyclophosphamide when given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus tumors. The safety of these 2 combination therapies will also be compared. Objectives: OVERALL AIM: To improve choroid plexus tumor treatment through better understanding of the tumor biology and through increased knowledge about the benefit of specific treatment elements. Specific Objectives: The study will have a prephase to evaluate the feasibility of the following randomized study (main phase). Pre-Phase (completed 2005) Primary Specific Objective: To determine the number of patients accountable per year for randomization in a worldwide study. Secondary Specific Objective: To measure the number of drop outs and to describe the toxicity of the chemotherapy. Main Phase (started in 2006) Primary Specific Objective: To compare the survival times after cyclophosphamide based treatment with the survival times after carboplatin based treatment in choroid plexus tumor patients. Main Phase Secondary Specific Objectives: 1. To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based treatment with the resectability after two blocks of carboplatin based treatment. 2. To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based treatment with the response rates after two blocks of carboplatin based treatment. 3. To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors.

Timeline

Start
2005-09-02
Primary completion
2017-12-14
Completion
2017-12-14

Outcome

Outcome not reported

Stopped: “PI has left the institution”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 350 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 1 g Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Vincristine Small molecule 1.5 mg/m2 Intravenous