Treatment of Tumors of the Choroid Plexus Epithelium - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00500890

Purpose

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 carboplatin based treatment.
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.
To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors.

Condition	Intervention	Phase
Choroid Plexus Tumors	Drug: Carboplatin Drug: Cyclophosphamide Drug: Etoposide Drug: Vincristine Radiation: Radiation Therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cyclophosphamide Vincristine Etoposide Carboplatin Etoposide phosphate Vincristine sulfate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	September 2005
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Carboplatin + Etoposide + Vincristine	Drug: Carboplatin 350 mg/m^2 by vein, Over 2 Hours x 2 Days Other Name: Paraplatin 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. Other Names: RT XRT Radiotherapy
Experimental: 2 Cyclophosphamide + Etoposide + Vincristine	Drug: Cyclophosphamide 1 g/m^2 by vein, Over 1 Hour x 2 Days Other Names: Cytoxan Neosar 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. Other Names: RT XRT Radiotherapy

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The reference center has confirmed the receipt of slides sent (For randomization only = form 2)
The postoperative imaging has been done and the result is available (for randomization only = for form 2 only)
Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed metastases. (For randomization only = use form 2).
Indication criteria: Atypical choroid plexus papilloma or anaplastic choroid plexus papilloma histology with either metastases or postoperative residual tumor. (For randomization only = use form 2).
Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed metastases or residual tumor. (For randomization only = use form 2).
Informed consent signed (required for registration = form 1, and for randomization = form 2)
Patients must have the following: WBC > 2000/ul, platelets >85 000/ul, serum creatinine in normal range, pregnancy test negative, hearing loss less than 30dB at 3000 Hz.

Exclusion Criteria:

Previous irradiation or chemotherapy. (Exclusion from randomization only)
The protocol did not pass the local centre required approvals, such as the Ethics Committee or the scientific review.
Previous immunotherapy or antiangiogenic therapy (Exclusion from randomization only)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500890

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Michael E. Rytting, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wrede B, Hasselblatt M, Peters O, Thall PF, Kutluk T, Moghrabi A, Mahajan A, Rutkowski S, Diez B, Wang X, Pietsch T, Kortmann RD, Paulus W, Jeibmann A, Wolff JE. Atypical choroid plexus papilloma: clinical experience in the CPT-SIOP-2000 study. J Neurooncol. 2009 Dec;95(3):383-92. Epub 2009 Jun 20.

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00500890 History of Changes
Other Study ID Numbers:	2005-0398
Study First Received:	July 11, 2007
Last Updated:	October 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Choroid Plexus Tumors
Carboplatin
Cyclophosphamide
Etoposide

Vincristine
Paraplatin
Cytoxan
Neosar

Additional relevant MeSH terms:

Choroid Plexus Neoplasms
Cerebral Ventricle Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cyclophosphamide
Etoposide phosphate
Etoposide
Vincristine
Carboplatin

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on February 09, 2012