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Treatment of Tumors of the Choroid Plexus Epithelium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500890
Recruitment Status : Terminated (PI has left the institution)
First Posted : July 13, 2007
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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:

  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.

Condition or disease Intervention/treatment Phase
Choroid Plexus Tumors Drug: Carboplatin Drug: Cyclophosphamide Drug: Etoposide Drug: Vincristine Radiation: Radiation Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : September 2, 2005
Actual Primary Completion Date : December 14, 2017
Actual Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • RT
  • XRT
  • Radiotherapy

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:
  • 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




Primary Outcome Measures :
  1. Main Phase (Started in 2006) Primary Specific Objective [ Time Frame: After randomization until the end of the observation or the death of the patient ]
    To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.

  2. Secondary Objective SV40 [ Time Frame: No data were collected due to early termination ]
    To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors. Prognosis of tumors with or without SV40 will be compared using overall survival time as endpoint. Kaplan Meier survival estimates and log rank tests as statistical methods similar to the analysis of primary objective.


Secondary Outcome Measures :
  1. Secondary Objective Resectability [ Time Frame: No data were collected due to early termination ]
    To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based therapy treatment with the resectability after two blocks of carboplatin based treatment. Success of surgery after first 2 cycles of chemotherapy will be compared between two treatment arms. Percentage of patients with secondary complete remission from those with incomplete primary resection, will be used to analyze question. Tumor with CR and tumors which could be completely resected after two cycles of chemotherapy will be counted together. Frequency will be compared a month the 2 treatment arms using Chi-square test.

  2. Secondary Objective Response [ Time Frame: No data were collected due to early termination ]
    To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based therapy treatment with the response rates after two blocks of carboplatin based treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The reference center has confirmed the receipt of slides sent (For randomization only = form 2)
  2. The postoperative imaging has been done and the result is available (for randomization only = for form 2 only)
  3. Indication criteria: Choroid plexus papilloma (Gr I) with histologically confirmed metastases. (For randomization only = use form 2).
  4. 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).
  5. Indication criteria: Choroid plexus carcinoma, regardless of histologically confirmed metastases or residual tumor. (For randomization only = use form 2).
  6. Informed consent signed (required for registration = form 1, and for randomization = form 2)
  7. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500890


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Michael E. Rytting, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500890    
Other Study ID Numbers: 2005-0398
NCI-2012-01568 ( Registry Identifier: NCI CTRP )
First Posted: July 13, 2007    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Choroid Plexus Tumors
Carboplatin
Cyclophosphamide
Etoposide
Vincristine
Paraplatin
Cytoxan
Neosar
Additional relevant MeSH terms:
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Choroid Plexus Neoplasms
Neoplasms
Cerebral Ventricle Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cyclophosphamide
Carboplatin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators