Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00542971
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2007-10-10
Brief Title:
Phase I-II Study of Idarubicin Cytarabine and Sorafenib BAY43-9006
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I-II Study of Idarubicin Cytarabine and Sorafenib BAY43-9006 an Oral Vascular Endothelial Growth Factor VEGF Rapidly Accelerated Fibrosarcoma RAF and FMS-like Tyrosine Kinase 3 FLT3 in Patients With High-risk MDS and AML
Status:
COMPLETED
Status Verified Date:
2018-07
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:
A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia AML and high-risk myelodysplastic syndrome MDS
Once the highest safe dose is found researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients The safety of this treatment combination will also be studied
Once the highest safe dose is found researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients The safety of this treatment combination will also be studied
Detailed Description:
The Study Drugs
Sorafenib is designed to block the function of important proteins in cancer cells When active these proteins help cause abnormal growth and behavior of leukemia cells
Idarubicin and Ara-C are both designed to insert themselves into DNA the genetic material of cells and to stop DNA from repairing itself
Study Groups
If you are found to be eligible to take part in this study you will be assigned to a study group based on when you join this study
If you are enrolled in the Phase I part of this study the dose of sorafenib you receive with Ara-C and idarubicin will depend on when you enrolled in this study Each new group of 3 participants will receive a higher dose level of sorafenib than the previous group until the highest safe dose of sorafenib that can be given in combination with Ara-C and idarubicin is reached
If you are enrolled in the Phase II portion of this study you will receive the highest safe dose of sorafenib in combination with Ara-C and idarubicin found in the Phase I part
Study Drug Administration
During the study you will receive treatment over 28-day cycles The doses of idarubicin and Ara-C are the same for all study participants
On Days 1-4 Days 1-3 if you are older than 60 of each induction cycle 1 and possibly 2 you will receive Ara-C through a nonstop infusion through a needle in your vein You will also receive steroids by mouth or through a vein every day to reduce the risks of side effects such as rash
On Days 1-3 of each induction cycle 1 and possibly 2 you will receive idarubicin by vein over 1 hour once a day
In general sorafenib will be taken by mouth twice daily on Days 1-7 unless otherwise instructed However the dose of sorafenib may differ among study participants Sorafenib should be taken with water on an empty stomach Your study doctor will give you complete instructions on when and how to take sorafenib
Depending on the side effects that you may have the dose of sorafenib may be decreased stopped until side effects go away or even stopped completely if your doctor thinks that this is in your best interest
Study Visits
During Cycles 1-2 you will have study visits about 2 times a week You may need to have study visits more often when the study doctor thinks it is necessary At these visits you will have the following procedures performed
You will be asked about any side effects you may have experienced and any medications you may be taking
Blood about 2 teaspoons will be drawn for routine tests
During Cycles 1 and 2 between Days 21-28 you will have a bone marrow aspirate andor biopsy performed to check the status of the disease
For Cycle 3 and in further cycles you will have a bone marrow aspirate as determined necessary by your doctor If your doctor thinks you have responded to the treatment you will then have bone marrow aspirates collected every 3-6 months if your doctor feels this to be necessary
Consolidation Therapy
If it is found that the disease is responding to treatment you may receive 5 additional cycles of therapy These cycles are called consolidation therapy and will be given every 4-6 weeks
On Days 1-3 Ara-C will be given as a nonstop infusion You will also receive steroids either by mouth or by vein to help reduce the risk of side effects
On Days 1-2 idarubicin will be given by vein over 1 hour
Sorafenib will be taken twice daily by mouth for 7 or more days at a schedule determined by your study doctor
After each cycle about every 4-6 weeks blood about 2 teaspoons will be drawn to check your blood count levels
Maintenance Therapy
After 5 cycles of consolidation therapy and according to your response to consolidation therapy you may continue on this study to receive maintenance treatment as needed and as determined by your study doctor for up to 7 more cycles
You will take sorafenib twice a day every day during the 28-day cycle
Every 1-4 weeks blood about 2 teaspoons will be drawn for routine tests
Length of Study
You may receive up to 14 cycles in total of therapy You may be taken off this study if the leukemia gets worse develop another illness that interferes with taking the study drugs or you have intolerable side effects
This is an investigational study Sorafenib is FDA approved and commercially available for the treatment of metastatic renal cancer only Idarubicin is FDA approved for use in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia AML in adults Cytarabine is FDA approved for use in the treatment of leukemia The use of sorafenib combined with idarubicin and Ara-C in the treatment of AML and high-risk MDS is investigational and authorized for use in research only Up to 75 patients will take part in this study All patients will be enrolled at M D Anderson Cancer Center
Sorafenib is designed to block the function of important proteins in cancer cells When active these proteins help cause abnormal growth and behavior of leukemia cells
Idarubicin and Ara-C are both designed to insert themselves into DNA the genetic material of cells and to stop DNA from repairing itself
Study Groups
If you are found to be eligible to take part in this study you will be assigned to a study group based on when you join this study
If you are enrolled in the Phase I part of this study the dose of sorafenib you receive with Ara-C and idarubicin will depend on when you enrolled in this study Each new group of 3 participants will receive a higher dose level of sorafenib than the previous group until the highest safe dose of sorafenib that can be given in combination with Ara-C and idarubicin is reached
If you are enrolled in the Phase II portion of this study you will receive the highest safe dose of sorafenib in combination with Ara-C and idarubicin found in the Phase I part
Study Drug Administration
During the study you will receive treatment over 28-day cycles The doses of idarubicin and Ara-C are the same for all study participants
On Days 1-4 Days 1-3 if you are older than 60 of each induction cycle 1 and possibly 2 you will receive Ara-C through a nonstop infusion through a needle in your vein You will also receive steroids by mouth or through a vein every day to reduce the risks of side effects such as rash
On Days 1-3 of each induction cycle 1 and possibly 2 you will receive idarubicin by vein over 1 hour once a day
In general sorafenib will be taken by mouth twice daily on Days 1-7 unless otherwise instructed However the dose of sorafenib may differ among study participants Sorafenib should be taken with water on an empty stomach Your study doctor will give you complete instructions on when and how to take sorafenib
Depending on the side effects that you may have the dose of sorafenib may be decreased stopped until side effects go away or even stopped completely if your doctor thinks that this is in your best interest
Study Visits
During Cycles 1-2 you will have study visits about 2 times a week You may need to have study visits more often when the study doctor thinks it is necessary At these visits you will have the following procedures performed
You will be asked about any side effects you may have experienced and any medications you may be taking
Blood about 2 teaspoons will be drawn for routine tests
During Cycles 1 and 2 between Days 21-28 you will have a bone marrow aspirate andor biopsy performed to check the status of the disease
For Cycle 3 and in further cycles you will have a bone marrow aspirate as determined necessary by your doctor If your doctor thinks you have responded to the treatment you will then have bone marrow aspirates collected every 3-6 months if your doctor feels this to be necessary
Consolidation Therapy
If it is found that the disease is responding to treatment you may receive 5 additional cycles of therapy These cycles are called consolidation therapy and will be given every 4-6 weeks
On Days 1-3 Ara-C will be given as a nonstop infusion You will also receive steroids either by mouth or by vein to help reduce the risk of side effects
On Days 1-2 idarubicin will be given by vein over 1 hour
Sorafenib will be taken twice daily by mouth for 7 or more days at a schedule determined by your study doctor
After each cycle about every 4-6 weeks blood about 2 teaspoons will be drawn to check your blood count levels
Maintenance Therapy
After 5 cycles of consolidation therapy and according to your response to consolidation therapy you may continue on this study to receive maintenance treatment as needed and as determined by your study doctor for up to 7 more cycles
You will take sorafenib twice a day every day during the 28-day cycle
Every 1-4 weeks blood about 2 teaspoons will be drawn for routine tests
Length of Study
You may receive up to 14 cycles in total of therapy You may be taken off this study if the leukemia gets worse develop another illness that interferes with taking the study drugs or you have intolerable side effects
This is an investigational study Sorafenib is FDA approved and commercially available for the treatment of metastatic renal cancer only Idarubicin is FDA approved for use in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia AML in adults Cytarabine is FDA approved for use in the treatment of leukemia The use of sorafenib combined with idarubicin and Ara-C in the treatment of AML and high-risk MDS is investigational and authorized for use in research only Up to 75 patients will take part in this study All patients will be enrolled at M D Anderson Cancer Center
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