Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500890
Status:
TERMINATED
Last Update Posted:
2020-02-27
First Post:
2007-07-11
Brief Title:
Treatment of Tumors of the Choroid Plexus Epithelium
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI has left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 radiationchemotherapy 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
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 radiationchemotherapy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01568 | REGISTRY | NCI CTRP | None |