Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360438
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2006-08-02
Brief Title:
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia andor Lymphoma at High Risk of TLS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pharmacokinetic Evaluation of Rasburicase Dosed for 5 Consecutive Days as Uricolytic Therapy in Adult Patients With Leukemia andor Lymphoma at High or Potential Risk of Tumor Lysis Syndrome TLS
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
Primary
1 To determine the pharmacokinetic PK parameters of rasburicase in adult patients with leukemia andor lymphoma at high risk or potential risk of tumor lysis syndrome TLS
Secondary
1 To evaluate plasma uric acid AUC from baseline within 4 hours prior to first rasburicase treatment through 48 hours after the last per-protocol planned administration of rasburicase treatment
2 To evaluate the safety of rasburicase in adult patients with leukemia andor lymphoma
3 To evaluate incidence duration and type of immune responses IgG IgE and neutralizing antibody to rasburicase
1 To determine the pharmacokinetic PK parameters of rasburicase in adult patients with leukemia andor lymphoma at high risk or potential risk of tumor lysis syndrome TLS
Secondary
1 To evaluate plasma uric acid AUC from baseline within 4 hours prior to first rasburicase treatment through 48 hours after the last per-protocol planned administration of rasburicase treatment
2 To evaluate the safety of rasburicase in adult patients with leukemia andor lymphoma
3 To evaluate incidence duration and type of immune responses IgG IgE and neutralizing antibody to rasburicase
Detailed Description:
Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the start of chemotherapy A high level of uric acid may lead to reduced kidney function or kidney failure
TLS occurs when high uric acid levels are caused by breakdown of tumor cells after the start of chemotherapy The dead tumor cells can release uric acid and other symptoms of kidney failure such as excessive amounts of potassium and phosphorus into the blood
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study Your complete medical history will be recorded and you will have a physical exam including measurement of your vital signs blood pressure heart rate temperature and breathing rate height and weight You will have blood drawn about 2 tablespoons for routine tests Women who are able to have children must have a negative blood a sample will be used from the routine blood draw or urine pregnancy test
If you are found to be eligible to take part in this study you will receive rasburicase by a needle in your vein over 30 minutes once a day for 5 days in a row You will receive chemotherapy within 4-24 hours after your first dose of rasburicase
On Days 1-5 study drug treatment period you will have a physical exam including measurement of your vital signs During this time you will have blood drawn about 2 tablespoons each once a day for routine tests
You will have blood drawn less than 1 teaspoon each for PK testing at different time points throughout this study PK tests measure the level of the study drug in the blood at different times You will have a total of 14 samples drawn Your blood will be drawn on Day 1 before your dose of rasburicase and then at 30 minutes and at 4 8 24 48 72 96 965100104120 Day 6168 Day 8 and 336 Day 15 hours after your dose of the study drug
You will have blood drawn less than 1 teaspoon each to measure the level of uric acid in your blood at different time points throughout this study so that researchers can learn the effectiveness of the study drug on your disease You will have a total of 7 samples drawn Your blood will be drawn on Day 1 before your dose of rasburicase and then at 4 24 48 72 96120 Day 6 and 144 Day 7 hours after your dose of the study drug
You will also have blood drawn less than 1 teaspoon each for antibody testing at different time points throughout this study Antibody testing is a method to check for proteins IgG made by your body that show that your body is reacting to rasburicase You will have at least 5 samples drawn Your blood will be drawn on Day 1 before your dose of rasburicase and then on Day 14 Day 35 and at 3 and 6 months after your dose of the study drug
If you have a positive IgG antibody protein at the 6-month blood draw for antibody testing you will continue to have blood drawn less than 1 teaspoon every 6 months until your antibody protein is negative
If you experience any side effects related to allergic reactions during treatment with the study drug up to 30 days after your last dose of the study drug you will have an additional blood draw less than 1 teaspoon for antibody testing within 48 hours after having the reaction
You will be taken off this study if your disease gets worse or you experience any intolerable side effects
You will have assessments after the end of your study drug treatment from Days 1 to 5 These assessments will include a physical exam including measurement of your vital signs on Days 14 and 35 You will also have blood drawn about 2 tablespoons each for routine tests on Days 8 and 14
This is an investigational study Rasburicase is authorized by the FDA for use in adults in research only Rasburicase will be provided free of charge during this study Up to 20 patients will take part in this multicenter study Up to 20 can be enrolled at M D Anderson
TLS occurs when high uric acid levels are caused by breakdown of tumor cells after the start of chemotherapy The dead tumor cells can release uric acid and other symptoms of kidney failure such as excessive amounts of potassium and phosphorus into the blood
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study Your complete medical history will be recorded and you will have a physical exam including measurement of your vital signs blood pressure heart rate temperature and breathing rate height and weight You will have blood drawn about 2 tablespoons for routine tests Women who are able to have children must have a negative blood a sample will be used from the routine blood draw or urine pregnancy test
If you are found to be eligible to take part in this study you will receive rasburicase by a needle in your vein over 30 minutes once a day for 5 days in a row You will receive chemotherapy within 4-24 hours after your first dose of rasburicase
On Days 1-5 study drug treatment period you will have a physical exam including measurement of your vital signs During this time you will have blood drawn about 2 tablespoons each once a day for routine tests
You will have blood drawn less than 1 teaspoon each for PK testing at different time points throughout this study PK tests measure the level of the study drug in the blood at different times You will have a total of 14 samples drawn Your blood will be drawn on Day 1 before your dose of rasburicase and then at 30 minutes and at 4 8 24 48 72 96 965100104120 Day 6168 Day 8 and 336 Day 15 hours after your dose of the study drug
You will have blood drawn less than 1 teaspoon each to measure the level of uric acid in your blood at different time points throughout this study so that researchers can learn the effectiveness of the study drug on your disease You will have a total of 7 samples drawn Your blood will be drawn on Day 1 before your dose of rasburicase and then at 4 24 48 72 96120 Day 6 and 144 Day 7 hours after your dose of the study drug
You will also have blood drawn less than 1 teaspoon each for antibody testing at different time points throughout this study Antibody testing is a method to check for proteins IgG made by your body that show that your body is reacting to rasburicase You will have at least 5 samples drawn Your blood will be drawn on Day 1 before your dose of rasburicase and then on Day 14 Day 35 and at 3 and 6 months after your dose of the study drug
If you have a positive IgG antibody protein at the 6-month blood draw for antibody testing you will continue to have blood drawn less than 1 teaspoon every 6 months until your antibody protein is negative
If you experience any side effects related to allergic reactions during treatment with the study drug up to 30 days after your last dose of the study drug you will have an additional blood draw less than 1 teaspoon for antibody testing within 48 hours after having the reaction
You will be taken off this study if your disease gets worse or you experience any intolerable side effects
You will have assessments after the end of your study drug treatment from Days 1 to 5 These assessments will include a physical exam including measurement of your vital signs on Days 14 and 35 You will also have blood drawn about 2 tablespoons each for routine tests on Days 8 and 14
This is an investigational study Rasburicase is authorized by the FDA for use in adults in research only Rasburicase will be provided free of charge during this study Up to 20 patients will take part in this multicenter study Up to 20 can 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