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Treatment of Tumors of the Choroid Plexus Epithelium

Primary Purpose

Choroid Plexus Tumors

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Cyclophosphamide
Etoposide
Vincristine
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroid Plexus Tumors focused on measuring Choroid Plexus Tumors, Carboplatin, Cyclophosphamide, Etoposide, Vincristine, Paraplatin, Cytoxan, Neosar

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carboplatin + Etoposide + Vincristine

Cyclophosphamide + Etoposide + Vincristine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Main Phase (Started in 2006) Primary Specific Objective
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.
Secondary Objective SV40
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

Secondary Objective Resectability
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.
Secondary Objective Response
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.

Full Information

First Posted
July 11, 2007
Last Updated
February 21, 2020
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00500890
Brief Title
Treatment of Tumors of the Choroid Plexus Epithelium
Official Title
A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
PI has left the institution
Study Start Date
September 2, 2005 (Actual)
Primary Completion Date
December 14, 2017 (Actual)
Study Completion Date
December 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed Description
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 chemotherapy was used to delay radiation therapy. Chemotherapy is the one and only additional treatment that participants under 3 years of age can receive in this study. After the first 2 cycles, response will be evaluated, including all exams done at screening before you continue on treatment, if needed. Further surgery will be considered after these exams. If both you and your doctor choose to consider further surgery and agree for the procedure to be the next appropriate step, you may undergo a second surgery to remove anymore remaining tumor. After the second surgery, the chemotherapy will be again continued on the same schedule for 4 more cycles. If you did not require further surgery, you will continue on with the chemotherapy as previously planned. For participants older than 3 years of age, radiation therapy will be a part of the treatment. It will be given after the second cycle of chemotherapy. Participants will receive radiation once per day, five days per week, over a period of about 6 weeks. Most of the participants do not need to stay in the hospital during this time. This will be followed by 6 more cycles of chemotherapy. After 6 cycles of chemotherapy, further surgery will again be considered. While on radiation treatment, you will have blood (about 2 teaspoons) drawn for routine tests 2 times a week. Before and after the finish of radiation, another blood test (2-3 teaspoons) will be taken to monitor the kidney and liver function, as well as to measure levels of hormones. You will have a physical exam, and blood (about 2 teaspoons) will be drawn for routine tests before each cycle of treatment. Participants in the carboplatin group will receive etoposide over 1 hour on Days 1-5, carboplatin over 2 hours on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will be repeated every 4 weeks for 24 weeks. Each period of 4 weeks is considered 1 cycle of treatment. Participants in the cyclophosphamide group will receive etoposide over 1 hour on Days 1-5, cyclophosphamide over 1 hour on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will be repeated every 4 weeks for 6 cycles (24 weeks) of treatment. Mesna, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide. The chemotherapy given in this study can cause your white blood cell count to be too low. White blood cells are infection-fighting cells. If the white blood cell count is low for too long, participants in both groups may be given a drug called G-CSF (filgrastim). Filgrastim is a growth factor naturally produced in the body to increase the production of white blood cells. Filgrastim will be given as a shot under the skin starting at Day 9 after starting the chemotherapy. The total length of treatment that you can receive will be 7 months, if you are able to complete all the cycles of the additional treatment. You will be taken off study if the disease gets worse or intolerable side effects occur, and your doctor will discuss other treatment options with you. After completing treatment, there will be follow-up visits every 3 months for the first year. Every 6 months there will still be visits with the doctor until 4 years after completing treatment. You will continue to have follow-up visits every year after that to monitor for any signs of the disease coming back, or for as long as you would agree to allow follow-up visits. At each visit, you will have routine blood tests (about 2-3 teaspoons), checking of hormone levels, measurement of growth, and a hearing test. The effects of radiation/chemotherapy on your brain function, your ability to learn, and your quality of life will be measured. You will have a MRI of the brain, all known metastatic sites, and of the spine. Your body height and body weight will be measured. About 2 teaspoons of blood will be drawn for routine tests. Your urine will be tested for the presence of blood. You will have a spinal tap to look for cancer cells in the spinal fluid. Your hormone levels will also be taken to see if there are any signs of metabolic disorder and growth deficiency. This will be done with the other blood test and will not require any more extra blood samples from you. This is an investigational study. All of the drugs used in this study are FDA approved and are commercially available. Their use together in this study is experimental. A total of up to 100 patients will take part in this multicenter study. Up to 5 will be enrolled here at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroid Plexus Tumors
Keywords
Choroid Plexus Tumors, Carboplatin, Cyclophosphamide, Etoposide, Vincristine, Paraplatin, Cytoxan, Neosar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin + Etoposide + Vincristine
Arm Type
Experimental
Arm Description
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.
Arm Title
Cyclophosphamide + Etoposide + Vincristine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
350 mg/m^2 by vein, Over 2 Hours x 2 Days
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan, Neosar
Intervention Description
1 g/m^2 by vein, Over 1 Hour x 2 Days
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
100 mg/m^2 by vein, Over 1 Hour x 5 Days
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1.5 mg/m^2 (by vein)IV Push Over 15 Minutes On Day 5
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
RT, XRT, Radiotherapy
Intervention Description
Radiation treatment over a period of about 6 weeks.
Primary Outcome Measure Information:
Title
Main Phase (Started in 2006) Primary Specific Objective
Description
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.
Time Frame
After randomization until the end of the observation or the death of the patient
Title
Secondary Objective SV40
Description
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.
Time Frame
No data were collected due to early termination
Secondary Outcome Measure Information:
Title
Secondary Objective Resectability
Description
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.
Time Frame
No data were collected due to early termination
Title
Secondary Objective Response
Description
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.
Time Frame
No data were collected due to early termination

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E. Rytting, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19543851
Citation
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 JEA. Atypical choroid plexus papilloma: clinical experience in the CPT-SIOP-2000 study. J Neurooncol. 2009 Dec;95(3):383-392. doi: 10.1007/s11060-009-9936-y. Epub 2009 Jun 20.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Treatment of Tumors of the Choroid Plexus Epithelium

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