Treatment of Tumors of the Choroid Plexus Epithelium
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500890
First received: July 11, 2007
Last updated: October 11, 2012
Last verified: October 2012
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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 3 |
| 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 sulfate
Etoposide
Carboplatin
Etoposide phosphate
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 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Carboplatin + Etoposide + Vincristine
Carboplatin 350 mg/m^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.
|
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:
|
|
Experimental: Cyclophosphamide + Etoposide + Vincristine
Cyclophosphamide 1 g/m^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.
|
Drug: Cyclophosphamide
1 g/m^2 by vein, Over 1 Hour x 2 Days
Other Names:
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:
|
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:
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 11, 2012 |
| 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 May 23, 2013