Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424645
Status:
TERMINATED
Last Update Posted:
2012-12-06
First Post:
2007-01-17
Brief Title:
Voraxaze for Delayed Methotrexate Clearance
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Double-Blind Placebo Controlled Trial of Voraxaze in Patients With a Delayed MTX Clearance
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To evaluate the efficacy of Glucarpidase Voraxaze in increasing the rate of methotrexate MTX clearance following high dose MTX treatment in patients with a delayed MTX clearance
2 To evaluate the pharmacokinetics PK of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance
3 To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance
Secondary Objectives
1 To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous IV antibiotics
2 To evaluate the effect of Glucarpidase on the length of hospitalization
3 To evaluate the effect of Glucarpidase on renal function
4 To evaluate the effect of Glucarpidase on Quality of Life QOL
5 To evaluate the anti-glucarpidase antibody response
6 To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment
1 To evaluate the efficacy of Glucarpidase Voraxaze in increasing the rate of methotrexate MTX clearance following high dose MTX treatment in patients with a delayed MTX clearance
2 To evaluate the pharmacokinetics PK of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance
3 To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance
Secondary Objectives
1 To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous IV antibiotics
2 To evaluate the effect of Glucarpidase on the length of hospitalization
3 To evaluate the effect of Glucarpidase on renal function
4 To evaluate the effect of Glucarpidase on Quality of Life QOL
5 To evaluate the anti-glucarpidase antibody response
6 To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment
Detailed Description:
Researchers want to learn how glucarpidase may impact patients length of stay in the hospital kidney function and quality of life Also researchers want to learn if glucarpidase may decrease the incidence of neutropenic fever which may decrease the use of antibiotics by vein to treat this kind of fever
MTX is a high-dose chemotherapy drug that reduces the supply of an important vitamin folate required for the growth of cancer cells In patients with delayed clearance of MTX from the body there is a risk of more frequent or severe side effects from the drug
Glucarpidase is a drug that breaks down MTX in the blood causing the drug to be less toxic and decreasing levels of the drug in 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 You will have a physical exam including measurement of your vital signs temperature pulse breathing rate and blood pressure You will have blood drawn about 3 teaspoons for routine tests You will also have blood drawn about 1 teaspoon right before treatment starts 28 days after the first dose of study drug in each cycle and at the end of the study to see if you have any antibodies proteins in the body that help fight infections and foreign substances in the body to the study drug Women who are able to have children must have a negative blood pregnancy test The blood used for the pregnancy test will come from the sample taken for routine tests There is no additional blood draw for the pregnancy test
You may be given either glucarpidase or placebo a drug that looks like glucarpidase but is not active Neither you nor the study doctor will know if you have been given glucarpidase or placebo This is called the blinded phase of this study Before you can begin on this study if you are already suffering from side effects because of difficulty with MTX clearance such as kidney toxicity severe mucositis redness and painful ulcers in the mouth andor you have extremely high MTX levels you will not be randomized and will receive glucarpidase not placebo If this is the case your doctor will know that you have been given glucarpidase
If you are found to be eligible to take part in this study you will be assigned to 1 of 2 treatment groups which will be based on the dose of MTX you received You will then be randomly assigned as in the toss of a coin to one of two treatment groups Participants in one group will receive glucarpidase Participants in the other group will receive placebo There is a higher chance that you may receive glucarpidase than placebo because for every patient that receives placebo 2 patients will receive glucarpidase The glucarpidase or placebo dose that you may receive will be given by vein within 12 hours after you have been found eligible to participate in this study Glucarpidase or placebo will be given during the first study cycle after MTX treatment is completed if after 72 hours your MTX levels are found to be high You may receive additional doses of glucarpidase depending upon the level of MTX in your blood up to a maximum of 2 doses If this is the case the second dose will be given at least 24 hours after the first dose you received
Regardless of the treatment group that you are assigned to you will continue to receive standard treatment fluids by vein with sodium acetate or sodium bicarbonate and leucovorin for high MTX levels In future cycles of MTX you may receive glucarpidase if you continue to experience a delay of MTX clearing from your body The glucarpidase dose may be repeated a maximum of 2 times in a given cycle of chemotherapy The length of a cycle of chemotherapy will vary depending on the dose of MTX and the regimen the patient is receiving One cycle of treatment with glucarpidase is at least 24 hours apart
You will be asked to fill out several questionnaires regarding your quality of life These questionnaires will ask about your level of pain fatigue nausea sleep disturbances etc They will be given during the first study cycle only before the study drug is given and daily during the first study cycle They will take about 5 minutes to complete each time
You will also have blood drawn about 3 teaspoons each at different times so that study doctors can monitor your kidney function and liver function depending on your clinical condition These blood samples will be drawn at least twice a week while you are on this study You will again have blood drawn for the presence of antibodies 14 days after treatment with glucarpidase before every cycle of MTX treatment and at the end of this study
You will be taken off this study if your disease gets worse you experience intolerable side effects or you completed planned therapy a maximum of 6 cycles of study drug At the end of this study your complete medical history will again be recorded You will have a physical exam including measurement of your vital signs You will also have blood drawn about 1 teaspoon for routine tests
This is an investigational study Glucarpidase is not FDA approved or commercially available The M D Anderson Institutional Review Board IRB has authorized the use of glucarpidase for research only The IRB is a committee made up of doctors researchers and members of the community The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner Glucarpidase and placebo will be provided free of charge during this study Up to 46 patients will take part in this study All patients will be enrolled at M D Anderson
MTX is a high-dose chemotherapy drug that reduces the supply of an important vitamin folate required for the growth of cancer cells In patients with delayed clearance of MTX from the body there is a risk of more frequent or severe side effects from the drug
Glucarpidase is a drug that breaks down MTX in the blood causing the drug to be less toxic and decreasing levels of the drug in 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 You will have a physical exam including measurement of your vital signs temperature pulse breathing rate and blood pressure You will have blood drawn about 3 teaspoons for routine tests You will also have blood drawn about 1 teaspoon right before treatment starts 28 days after the first dose of study drug in each cycle and at the end of the study to see if you have any antibodies proteins in the body that help fight infections and foreign substances in the body to the study drug Women who are able to have children must have a negative blood pregnancy test The blood used for the pregnancy test will come from the sample taken for routine tests There is no additional blood draw for the pregnancy test
You may be given either glucarpidase or placebo a drug that looks like glucarpidase but is not active Neither you nor the study doctor will know if you have been given glucarpidase or placebo This is called the blinded phase of this study Before you can begin on this study if you are already suffering from side effects because of difficulty with MTX clearance such as kidney toxicity severe mucositis redness and painful ulcers in the mouth andor you have extremely high MTX levels you will not be randomized and will receive glucarpidase not placebo If this is the case your doctor will know that you have been given glucarpidase
If you are found to be eligible to take part in this study you will be assigned to 1 of 2 treatment groups which will be based on the dose of MTX you received You will then be randomly assigned as in the toss of a coin to one of two treatment groups Participants in one group will receive glucarpidase Participants in the other group will receive placebo There is a higher chance that you may receive glucarpidase than placebo because for every patient that receives placebo 2 patients will receive glucarpidase The glucarpidase or placebo dose that you may receive will be given by vein within 12 hours after you have been found eligible to participate in this study Glucarpidase or placebo will be given during the first study cycle after MTX treatment is completed if after 72 hours your MTX levels are found to be high You may receive additional doses of glucarpidase depending upon the level of MTX in your blood up to a maximum of 2 doses If this is the case the second dose will be given at least 24 hours after the first dose you received
Regardless of the treatment group that you are assigned to you will continue to receive standard treatment fluids by vein with sodium acetate or sodium bicarbonate and leucovorin for high MTX levels In future cycles of MTX you may receive glucarpidase if you continue to experience a delay of MTX clearing from your body The glucarpidase dose may be repeated a maximum of 2 times in a given cycle of chemotherapy The length of a cycle of chemotherapy will vary depending on the dose of MTX and the regimen the patient is receiving One cycle of treatment with glucarpidase is at least 24 hours apart
You will be asked to fill out several questionnaires regarding your quality of life These questionnaires will ask about your level of pain fatigue nausea sleep disturbances etc They will be given during the first study cycle only before the study drug is given and daily during the first study cycle They will take about 5 minutes to complete each time
You will also have blood drawn about 3 teaspoons each at different times so that study doctors can monitor your kidney function and liver function depending on your clinical condition These blood samples will be drawn at least twice a week while you are on this study You will again have blood drawn for the presence of antibodies 14 days after treatment with glucarpidase before every cycle of MTX treatment and at the end of this study
You will be taken off this study if your disease gets worse you experience intolerable side effects or you completed planned therapy a maximum of 6 cycles of study drug At the end of this study your complete medical history will again be recorded You will have a physical exam including measurement of your vital signs You will also have blood drawn about 1 teaspoon for routine tests
This is an investigational study Glucarpidase is not FDA approved or commercially available The M D Anderson Institutional Review Board IRB has authorized the use of glucarpidase for research only The IRB is a committee made up of doctors researchers and members of the community The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner Glucarpidase and placebo will be provided free of charge during this study Up to 46 patients will take part in this study All patients 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