Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042367
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2002-07-26
Brief Title:
Study of Systemic and Spinal Chemotherapy Followed by Radiation for Infants With Brain Tumors
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Pilot Study of Systemic and Intrathecal Chemotherapy Followed by Conformal Radiation for Infants With Brain Tumors
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BB98
Brief Summary:
The purposes of this study are to find the highest dose of mafosfamide that can be given without causing severe side effects to see how well the combination of these chemotherapy drugs and lower doses of radiation work to delay or stop the growth of the tumor and to evaluate the pharmacokinetics how the body handles of Mafosfamide
Detailed Description:
All children in the study will receive Regimen 1 chemotherapy Children whose tumor is limited to one area at the beginning of the study will go on to have radiation therapy and then Regimen 2 chemotherapy Children whose tumor was found in more than one part of the brain or in the cerebrospinal fluid at the beginning of the study will discontinue their treatment on this protocol after Regimen 1 chemotherapy
Regimen 1 Chemotherapy - Those children with a normal CSF flow study at the beginning of the study will receive Regimen 1 chemotherapy along with mafosfamide Those children with an abnormal CSF flow study will receive Regimen 1 without mafosfamide and a repeat CSF flow study will be performed at the completion of the first 10 weeks of treatment If the CSF study reflects normal CSF flow then intrathecal mafosfamide will be given during the second 10 weeks of Regimen 1 Regimen 1 is divided into two courses Each course lasts about 10 weeks for a total of 20 weeks of treatment During Regimen 1 the patient will receive three medications cyclophosphamide vincristine and cisplatin that are given through the central venous line The patient will also receive one medication that is given by mouth etoposide Cyclophosphamide vincristine cisplatin and etoposide are all anticancer drugs that have been useful in the treatment of brain tumors
The experimental drug mafosfamide will be injected into the spinal fluid This will be given through either a spinal tap the Ommaya reservoir or both Alternating mafosfamide between the spinal tap and the Ommaya reservoir may improve how well the drug works by making sure it spreads throughout the spinal fluid If the patient has a VP or VA shunt specialized devices that relieve the pressure inside the head that comes from a block in the normal flow of spinal fluid then the patient will not receive an Ommaya reservoir and all doses of mafosfamide will be given through a spinal tap only
The starting dose of mafosfamide will be a dose that has been safely given to older children If that dose does not cause severe side effects the next group of patients will receive a higher dose of mafosfamide If severe side effects occur the next group of patients will receive a lower dose of mafosfamide
During and at the end of Regimen 1 the patient will be evaluated for response of the brain tumor to treatment A second operation may be necessary to remove more of the brain tumor Children whose tumor had spread at the time they began this study have completed treatment at this point Children whose tumor had not spread at start of the study will begin radiation therapy if their tumor appears to be unchanged or shrinking after Regimen 1
Radiation Therapy - The dose location and timing of radiation will depend on the age of the child at diagnosis the location of hisher tumor and the response of hisher tumor to Regimen 1 chemotherapy The radiation treatments used in this protocol are designed in an attempt to reduce some of the side effects that usually occur after standard radiation therapy
The child will receive radiation using a new technology called conformal radiation Conformal radiation is designed to reduce the amount of normal brain tissue that is exposed to high doses of radiation
Regimen 2 Chemotherapy - After radiation therapythe patient will receive additional chemotherapy which will last about 20 weeks Regimen 2 chemotherapy is the same as the Regimen 1 chemotherapy except that the patient will not be given the drugs cisplatin and mafosfamide
Pharmacokinetic PK studies will be performed with a total of 2 doses of intrathecal mafosfamide PK studies tell us how the patients body handles the study drug mafosfamide Sampling times times when we collect cerebrospinal fluid for the PK studies will be prior to drug administration and at 10 minutes 2 hours and 4 hours following drug administration These studies will be performed after one dose of drug given through the spinal tap and after one dose of drug is given through the Ommaya reservoir The pharmacokinetic study is optional and you can choose not to allow these samples to be drawn Refusing the pharmacokinetic study will not affect the patients participationtreatment on this study
Regimen 1 Chemotherapy - Those children with a normal CSF flow study at the beginning of the study will receive Regimen 1 chemotherapy along with mafosfamide Those children with an abnormal CSF flow study will receive Regimen 1 without mafosfamide and a repeat CSF flow study will be performed at the completion of the first 10 weeks of treatment If the CSF study reflects normal CSF flow then intrathecal mafosfamide will be given during the second 10 weeks of Regimen 1 Regimen 1 is divided into two courses Each course lasts about 10 weeks for a total of 20 weeks of treatment During Regimen 1 the patient will receive three medications cyclophosphamide vincristine and cisplatin that are given through the central venous line The patient will also receive one medication that is given by mouth etoposide Cyclophosphamide vincristine cisplatin and etoposide are all anticancer drugs that have been useful in the treatment of brain tumors
The experimental drug mafosfamide will be injected into the spinal fluid This will be given through either a spinal tap the Ommaya reservoir or both Alternating mafosfamide between the spinal tap and the Ommaya reservoir may improve how well the drug works by making sure it spreads throughout the spinal fluid If the patient has a VP or VA shunt specialized devices that relieve the pressure inside the head that comes from a block in the normal flow of spinal fluid then the patient will not receive an Ommaya reservoir and all doses of mafosfamide will be given through a spinal tap only
The starting dose of mafosfamide will be a dose that has been safely given to older children If that dose does not cause severe side effects the next group of patients will receive a higher dose of mafosfamide If severe side effects occur the next group of patients will receive a lower dose of mafosfamide
During and at the end of Regimen 1 the patient will be evaluated for response of the brain tumor to treatment A second operation may be necessary to remove more of the brain tumor Children whose tumor had spread at the time they began this study have completed treatment at this point Children whose tumor had not spread at start of the study will begin radiation therapy if their tumor appears to be unchanged or shrinking after Regimen 1
Radiation Therapy - The dose location and timing of radiation will depend on the age of the child at diagnosis the location of hisher tumor and the response of hisher tumor to Regimen 1 chemotherapy The radiation treatments used in this protocol are designed in an attempt to reduce some of the side effects that usually occur after standard radiation therapy
The child will receive radiation using a new technology called conformal radiation Conformal radiation is designed to reduce the amount of normal brain tissue that is exposed to high doses of radiation
Regimen 2 Chemotherapy - After radiation therapythe patient will receive additional chemotherapy which will last about 20 weeks Regimen 2 chemotherapy is the same as the Regimen 1 chemotherapy except that the patient will not be given the drugs cisplatin and mafosfamide
Pharmacokinetic PK studies will be performed with a total of 2 doses of intrathecal mafosfamide PK studies tell us how the patients body handles the study drug mafosfamide Sampling times times when we collect cerebrospinal fluid for the PK studies will be prior to drug administration and at 10 minutes 2 hours and 4 hours following drug administration These studies will be performed after one dose of drug given through the spinal tap and after one dose of drug is given through the Ommaya reservoir The pharmacokinetic study is optional and you can choose not to allow these samples to be drawn Refusing the pharmacokinetic study will not affect the patients participationtreatment on this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None