Clinical Trial: Treatment of Tumors of the Choroid Plexus Epithelium
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors
Brief 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:
- To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based treatment with the resectability after two blocks of carboplat
Detailed Summary:
Tumors of the choroid plexus epithelium are rare. Participants in this study will have surgery to remove as much of the brain tumor as possible. Taking as much of the tumor out during surgery is generally believed to have the best result for this disease. Some participants may even have a second surgery to remove more tumor if thought necessary.
After the tumor surgery, exact treatment for each participant in this study will depend on how much of the tumor is removed during surgery and the way the tumor tissue looks under a microscope. Some participants will not require additional treatment because most or all of the tumor has been taken out. Those participants will still be on study, but they will only have observation and not receive additional treatment. Those that require additional treatment will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups with an equal chance of being assigned to either group.
Chemotherapy (treatment with anti-cancer drugs) will be given as part of treatment for participants whose tumors are not completely removed surgically. Participants in one group will receive carboplatin plus etoposide, vincristine, and radiation therapy . Participants in the other group will receive cyclophosphamide plus etoposide, vincristine, and radiation therapy. Among all the known drugs for cancer, etoposide, vincristine, cyclophosphamide, and platinum drugs are the most effective against brain tumors. Carboplatin will be used because fewer side effects related to hearing should occur later on. This study also uses radiation therapy after surgery for children younger than 3 years old. Normally, chemotherapy has been used to delay radiation therapy until the child was older because of concerns about side effects. This change has been made because of the poor results achieved when chemothera
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome: Main Phase: Overall Survival After Start of Additional Treatment [ Time Frame: Baseline, after two 4-week cycles, until disease progression -- survival time defined as time after randomization until end of observation or patient death. ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: July 11, 2007
Date Started: September 2005
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016
