Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511017
Status:
TERMINATED
Last Update Posted:
2012-07-31
First Post:
2007-08-02
Brief Title:
Doxercalciferol in Recurrent Pediatric Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors The safety of this drug will also be studied Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D
Detailed Description:
The Study Drug
Doxercalciferol is designed to copy the actions of Vitamin D without causing blood levels of calcium to be too high
Study Drug Dose Level
If you are found to be eligible to take part in this study you will begin receiving doxercalciferol The dose you will receive will be based on how many participants have been enrolled before you and on the safety data that is available You will remain on the same dose level throughout this study There will be up to 9 participants enrolled in each group of the same dose The first group of participants enrolled on this study will be given small doses of doxercalciferol If no intolerable side effects are experienced the next group of participants will be enrolled at a higher dose level This process will continue until researchers find the highest tolerable dose of doxercalciferol among the 5 dose levels being tested that can be given without intolerable side effects occurring
Study Drug Administration
If you are found to be eligible to take part in this study you will begin the first cycle of the study drug Each cycle of chemotherapy will last 28 days
Doxercalciferol will be taken by mouth every day for 28 days
Study Visits
Every week during Cycle 1 you will have a physical exam and urine will be collected for routine tests
Two 2 times every week while you are on study blood about 2 teaspoons will be drawn for routine tests
During Cycles 2 and beyond you will have the following tests and procedures performed
Urine will be collected for routine tests
ECG and ECHO will be repeated again only if your doctor feels it is necessary
You may also have a computed tomography CT scan andor magnetic resonance imaging MRI to check the status of the disease
Length of Study
You may remain on this study for up to 12 cyclesYou will be taken off this study if the disease gets worse or intolerable side effects occur The study doctor may stop you from taking part in this study at any time if heshe believes it is in your best interest or if you do not follow the study rules
You can stop participating in this study at any time Tell the study doctor if you are thinking about leaving the study so that any risks can be reviewed by your study doctor and so that follow-up care and testing can be discussed The study doctor will tell you how to stop safely
End-of-Study Visit
Once you are off-study you will have an end-of-study visit At this visit the following tests and procedures will be performed
You will have a physical exam
Blood around 2 teaspoons and urine will be collected for routine tests
You may also have a CT scan andor MRI to check the status of the disease
Long-Term Follow-Up
After the end-of-study visit you will have a study visit every month for the first year and then once a year for 10 years At these visits you will have a physical exam
You may also have CT scans andor MRIs every 8 weeks for the 1st 6 months every 3 months for the next year then every 6 months for 1 12 years and then at least 1 time a year after that This will be done to check the status of your disease
Researchers would like to keep track of your medical condition and some general health information about you through yearly follow-up visits letters andor phone contact for up to 10 years More information such as other treatments andor disease response will be collected if follow-up studies show changes in the disease or in your overall health
If the disease has gotten worse researchers will keep track of which parts of your body are involved Researchers will also collect information about any other cancers or major organ problems you might have developed Keeping in touch with you and checking on your condition will help researchers look at the long-term effects of the study
This is an investigational study Doxercalciferol is FDA approved and commercially available for reducing high levels of a hormone in patients undergoing chronic renal dialysis Its use in this study for this disease is investigational
Up to 24 patients will take part in the study All will be enrolled at M D Anderson
Doxercalciferol is designed to copy the actions of Vitamin D without causing blood levels of calcium to be too high
Study Drug Dose Level
If you are found to be eligible to take part in this study you will begin receiving doxercalciferol The dose you will receive will be based on how many participants have been enrolled before you and on the safety data that is available You will remain on the same dose level throughout this study There will be up to 9 participants enrolled in each group of the same dose The first group of participants enrolled on this study will be given small doses of doxercalciferol If no intolerable side effects are experienced the next group of participants will be enrolled at a higher dose level This process will continue until researchers find the highest tolerable dose of doxercalciferol among the 5 dose levels being tested that can be given without intolerable side effects occurring
Study Drug Administration
If you are found to be eligible to take part in this study you will begin the first cycle of the study drug Each cycle of chemotherapy will last 28 days
Doxercalciferol will be taken by mouth every day for 28 days
Study Visits
Every week during Cycle 1 you will have a physical exam and urine will be collected for routine tests
Two 2 times every week while you are on study blood about 2 teaspoons will be drawn for routine tests
During Cycles 2 and beyond you will have the following tests and procedures performed
Urine will be collected for routine tests
ECG and ECHO will be repeated again only if your doctor feels it is necessary
You may also have a computed tomography CT scan andor magnetic resonance imaging MRI to check the status of the disease
Length of Study
You may remain on this study for up to 12 cyclesYou will be taken off this study if the disease gets worse or intolerable side effects occur The study doctor may stop you from taking part in this study at any time if heshe believes it is in your best interest or if you do not follow the study rules
You can stop participating in this study at any time Tell the study doctor if you are thinking about leaving the study so that any risks can be reviewed by your study doctor and so that follow-up care and testing can be discussed The study doctor will tell you how to stop safely
End-of-Study Visit
Once you are off-study you will have an end-of-study visit At this visit the following tests and procedures will be performed
You will have a physical exam
Blood around 2 teaspoons and urine will be collected for routine tests
You may also have a CT scan andor MRI to check the status of the disease
Long-Term Follow-Up
After the end-of-study visit you will have a study visit every month for the first year and then once a year for 10 years At these visits you will have a physical exam
You may also have CT scans andor MRIs every 8 weeks for the 1st 6 months every 3 months for the next year then every 6 months for 1 12 years and then at least 1 time a year after that This will be done to check the status of your disease
Researchers would like to keep track of your medical condition and some general health information about you through yearly follow-up visits letters andor phone contact for up to 10 years More information such as other treatments andor disease response will be collected if follow-up studies show changes in the disease or in your overall health
If the disease has gotten worse researchers will keep track of which parts of your body are involved Researchers will also collect information about any other cancers or major organ problems you might have developed Keeping in touch with you and checking on your condition will help researchers look at the long-term effects of the study
This is an investigational study Doxercalciferol is FDA approved and commercially available for reducing high levels of a hormone in patients undergoing chronic renal dialysis Its use in this study for this disease is investigational
Up to 24 patients will take part in the study All will be enrolled at M D Anderson
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