Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048373
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2002-10-30
Brief Title:
Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Treatment of Resistant Langerhans Cell Histiocytosis With Etanercept ENBREL IMMUNEX SEATTLE
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about the response of Langerhans cell histiocytosis LCH to Enbrel in patients who have failed to respond to standard therapies We are also looking specifically at what side effects Enbrel has on patients We expect to enroll 20 patients on this study and anticipate the subjects active participation to last up to one year
Detailed Description:
After subjects have completed the pretreatment evaluations they will receive an injection of Enbrel - the study drug -given under the skin twice weekly If the subjects disease stabilizes or regresses they may continue to receive treatment for up to 1 year
Subjects with disease involvement of risk organs this means patients have disease in their liver lung spleen or bone marrow will be admitted to the hospital for observation during the first week of administration of Enbrel If after the first two doses there appears to be no problems subjects may be followed as an outpatient with twice weekly evaluation visits similar to those performed before treatment began until abnormal blood tests have become normal Then the frequency of clinic visits will decrease and be similar to those described below for subjects without disease involvement of risk organs
Subjects without disease involvement of risk organs will be treated as an outpatient While receiving the treatment subjects may not receive any other chemotherapy agents Doctors will be monitoring subjects closely for side effects Most side effects usually disappear after the treatment is stopped In the meantime however the doctor may prescribe medication to keep these side effects under control
Subjects with disease involvement of risk organs this means patients have disease in their liver lung spleen or bone marrow will be admitted to the hospital for observation during the first week of administration of Enbrel If after the first two doses there appears to be no problems subjects may be followed as an outpatient with twice weekly evaluation visits similar to those performed before treatment began until abnormal blood tests have become normal Then the frequency of clinic visits will decrease and be similar to those described below for subjects without disease involvement of risk organs
Subjects without disease involvement of risk organs will be treated as an outpatient While receiving the treatment subjects may not receive any other chemotherapy agents Doctors will be monitoring subjects closely for side effects Most side effects usually disappear after the treatment is stopped In the meantime however the doctor may prescribe medication to keep these side effects under control
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Etanercept | None | None | None |