Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480987
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2007-05-30
Brief Title:
Oxaliplatin Fludarabine and Cytarabine in Acute Myeloid Leukemia AML or High-Risk Myelodysplastic Syndromes MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I-II Study of Oxaliplatin Fludarabine and Cytarabine in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes at First Relapse With Complete Remission Duration 1 Year
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of support
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 oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid Leukemia AML or High-Risk Myelodysplastic Syndromes MDS Once the highest tolerable dose of oxaliplatin in this drug combination is found the next goal of the study will be to learn the safety and the ability of the drug combination to control the disease
Detailed Description:
The Study Drugs
Cytarabine is designed to insert itself into Deoxyribonucleic acid DNA the genetic material of cells and stop the DNA from repairing itself
Fludarabine is designed to make cancer cells less able to repair damaged DNA This may increase the likelihood of the cells dying
Oxaliplatin is designed to program cells to cause death in leukemic cells
The Phases of The Study
This research study has 2 parts Phase I and Phase II
The Phase I part of the study will be used to test different dose levels in order to determine the highest tolerable dose of the study drug oxaliplatin that can be given in combination with cytarabine and fludarabine to patients with AML or high-risk MDS Three 3 participants will be enrolled at each dose level until the highest tolerable dose is found
The Phase II part of the study will evaluate the safety and disease-control ability of the study drug combination the highest tolerable dose that was found in order to treat these patients
Study Drug Administration
If you are found to be eligible to take part in this study you will be given oxaliplatin through a needle intravenously -- through an IV in your vein over 2 hours for 4 days Days 1-4 in a row
On Day 2 you will be given cytarabine through an IV in your vein by continuous infusion over 24 hours for 5 days Days 2-6 in a row Starting on Day 2 you will be given fludarabine through an IV in your vein over 30 minutes for 5 days Days 2-6 in a row In order to keep you from being dehydrated you will also be given other IV fluids such as saline a salt solution each day you receive the study drugs If the drugs are given on an outpatient basis a daily visit may take about 8 hours
One 1 cycle is 6 days long The first cycle will be given at M D Anderson Each cycle will be repeated every 4-6 weeks Depending on your response to the study drug combination you will have up to 5 more cycles either at M D Anderson or on an outpatient basis with your regular physician
Your study drug dose may be lowered if you experience severe side effects
Study Visits
During each treatment cycle you will have blood drawn about 1 teaspoon each time at least 2-3 times a week for routine tests You will have a bone marrow aspiration done on Day 21 of Cycle 1 and once a week thereafter unless there is clear evidence of active disease To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
Length of Study
You will remain on this study for up to 6 cycles for a total of about 6 months unless the disease is not responding the disease gets worse or you experience intolerable side effects If you are taken off this study early your study doctor will discuss other treatment options with you
End-of-Treatment Visit
Once you have completed treatment on this study you will have an end-of-treatment visit This visit will include routine blood tests about 1 teaspoon will be drawn each time and a bone marrow aspirate to check the status of the disease If your blood tests show the disease has gotten worse no bone marrow aspirate will be needed
Long-Term Follow-up
After your last cycle of treatment is completed and every 3 months for as long as you are in remission you will have blood drawn about 2 teaspoons each for routine testing
This is an investigational study Cytarabine is Food and Drug Administration FDA approved and commercially available for the treatment of AML and other blood cancers Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia CLL Oxaliplatin is FDA approved and commercially available for the treatment of advanced colorectal cancer and colon cancer Their use in combination is investigational in this study
Cytarabine is designed to insert itself into Deoxyribonucleic acid DNA the genetic material of cells and stop the DNA from repairing itself
Fludarabine is designed to make cancer cells less able to repair damaged DNA This may increase the likelihood of the cells dying
Oxaliplatin is designed to program cells to cause death in leukemic cells
The Phases of The Study
This research study has 2 parts Phase I and Phase II
The Phase I part of the study will be used to test different dose levels in order to determine the highest tolerable dose of the study drug oxaliplatin that can be given in combination with cytarabine and fludarabine to patients with AML or high-risk MDS Three 3 participants will be enrolled at each dose level until the highest tolerable dose is found
The Phase II part of the study will evaluate the safety and disease-control ability of the study drug combination the highest tolerable dose that was found in order to treat these patients
Study Drug Administration
If you are found to be eligible to take part in this study you will be given oxaliplatin through a needle intravenously -- through an IV in your vein over 2 hours for 4 days Days 1-4 in a row
On Day 2 you will be given cytarabine through an IV in your vein by continuous infusion over 24 hours for 5 days Days 2-6 in a row Starting on Day 2 you will be given fludarabine through an IV in your vein over 30 minutes for 5 days Days 2-6 in a row In order to keep you from being dehydrated you will also be given other IV fluids such as saline a salt solution each day you receive the study drugs If the drugs are given on an outpatient basis a daily visit may take about 8 hours
One 1 cycle is 6 days long The first cycle will be given at M D Anderson Each cycle will be repeated every 4-6 weeks Depending on your response to the study drug combination you will have up to 5 more cycles either at M D Anderson or on an outpatient basis with your regular physician
Your study drug dose may be lowered if you experience severe side effects
Study Visits
During each treatment cycle you will have blood drawn about 1 teaspoon each time at least 2-3 times a week for routine tests You will have a bone marrow aspiration done on Day 21 of Cycle 1 and once a week thereafter unless there is clear evidence of active disease To collect a bone marrow aspirate an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
Length of Study
You will remain on this study for up to 6 cycles for a total of about 6 months unless the disease is not responding the disease gets worse or you experience intolerable side effects If you are taken off this study early your study doctor will discuss other treatment options with you
End-of-Treatment Visit
Once you have completed treatment on this study you will have an end-of-treatment visit This visit will include routine blood tests about 1 teaspoon will be drawn each time and a bone marrow aspirate to check the status of the disease If your blood tests show the disease has gotten worse no bone marrow aspirate will be needed
Long-Term Follow-up
After your last cycle of treatment is completed and every 3 months for as long as you are in remission you will have blood drawn about 2 teaspoons each for routine testing
This is an investigational study Cytarabine is Food and Drug Administration FDA approved and commercially available for the treatment of AML and other blood cancers Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia CLL Oxaliplatin is FDA approved and commercially available for the treatment of advanced colorectal cancer and colon cancer Their use in combination is investigational in 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