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Treatment of Tumors of the Choroid Plexus Epithelium

NCT00500890 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-02-27

Study results available
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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.

Conditions

  • Choroid Plexus Tumors

Interventions

DRUG

Carboplatin

350 mg/m\^2 by vein, Over 2 Hours x 2 Days

DRUG

Cyclophosphamide

1 g/m\^2 by vein, Over 1 Hour x 2 Days

DRUG

Etoposide

100 mg/m\^2 by vein, Over 1 Hour x 5 Days

DRUG

Vincristine

1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5

RADIATION

Radiation Therapy

Radiation treatment over a period of about 6 weeks.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael E. Rytting, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-02
Primary Completion
2017-12-14
Completion
2017-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500890 on ClinicalTrials.gov