Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509600
Status:
TERMINATED
Last Update Posted:
2012-08-07
First Post:
2007-07-27
Brief Title:
Etanercept Enbrel for Juvenile Myelomonocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase IIA Window Study of Etanercept Enbrel for Juvenile Myelomonocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment study terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
11 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML
12 Determine if response to Tumor Necrosis Factor TNF blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia JMML mutations in NF1 Ras SHP2 or levels of TNFa
13 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts
14 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation
11 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML
12 Determine if response to Tumor Necrosis Factor TNF blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia JMML mutations in NF1 Ras SHP2 or levels of TNFa
13 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts
14 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation
Detailed Description:
Etanercept blocks a hormone called Tumor Necrosis Factor TNF which has been shown to play a role in helping the growth of leukemic cells in JMML
Before participants can start treatment on this study they will have what are called screening tests These tests will help the doctor decide if patients are eligible to take part in the study You will have a complete medical history and physical exam About two tablespoons of blood and urine will be collected for routine tests as well as to test for the liver and kidney function You will have a bone marrow biopsy performed to monitor disease activity To collect a bone marrow biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle You will have cells from inside of the mouth tested for genetic changes by swabbing the side of the cheeks
If you are found to be eligible etanercept will be given as an injection under the skin once a week for up to 90 days
During the study you will have weekly follow-up tests that will include physical exam and lab tests About 2 tablespoons of blood will be collected each time Urine will also be collected for testing at least every 3 weeks while on the study
If the disease gets worse or intolerable side effects occur you will be taken off study and alternative treatment options will be discussed
This is an investigational study The FDA has approved etanercept for use in adults and children with rheumatoid arthritis and juvenile rheumatoid arthritis Its use in this study is experimental A total of up to 30 patients will take part in this study All will be enrolled at M D Anderson
Before participants can start treatment on this study they will have what are called screening tests These tests will help the doctor decide if patients are eligible to take part in the study You will have a complete medical history and physical exam About two tablespoons of blood and urine will be collected for routine tests as well as to test for the liver and kidney function You will have a bone marrow biopsy performed to monitor disease activity To collect a bone marrow biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle You will have cells from inside of the mouth tested for genetic changes by swabbing the side of the cheeks
If you are found to be eligible etanercept will be given as an injection under the skin once a week for up to 90 days
During the study you will have weekly follow-up tests that will include physical exam and lab tests About 2 tablespoons of blood will be collected each time Urine will also be collected for testing at least every 3 weeks while on the study
If the disease gets worse or intolerable side effects occur you will be taken off study and alternative treatment options will be discussed
This is an investigational study The FDA has approved etanercept for use in adults and children with rheumatoid arthritis and juvenile rheumatoid arthritis Its use in this study is experimental A total of up to 30 patients will take part in this 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