Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038376
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2002-05-30
Brief Title:
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2018-10
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:
The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha Roferon and Isotretinoin Accutane
Detailed Description:
Retinoids have shown activity in T-cell malignancies in past studies both isotretinoin and etretinate with an overall response rate of about 60 One third of those responses were complete responses Interferon-alpha has proven efficacy in wide ranges of human malignancies including T-cell lymphomas as a single agent A clinical trial was needed to evaluate the response rate of these two agents combined
Interferon is a normal body protein which is made by cells after exposure to viruses It acts as a messenger to warn surrounding cells of invasions by viruses and possibly by cancer cells Isotretinoin is a synthetic form of Vitamin A which effects the growth of normal cells and cancer cells
Participants participating in this study will receive a combination of alpha-interferon and isotretinoin Alpha-interferon will be given once a day for an initial period of 12 weeks Participants will take the drug home where a nurse or family member of the participant who can be trained at UTMDACC will inject it just under the skin SQ Isotretinoin will be given by mouth twice a day
If a participants disease does not show a response the alpha-interferon and the isotretinoin will be increased If side effects occur the dose of alpha-interferon andor isotretinoin will be decreased by 50 If the side effects are severe therapy will be discontinued If the participants disease is unresponsive or worsens the participant will be taken off study and other treatments will be recommended
Responding participants will be placed on a maintenance schedule for as long as they respond Up to 60 participants will be studied at UT MD Anderson Cancer Center to test the effectiveness of this drug combination
This is an investigational study Alpha-interferon and isotretinoin are FDA approved and commercially available
Interferon is a normal body protein which is made by cells after exposure to viruses It acts as a messenger to warn surrounding cells of invasions by viruses and possibly by cancer cells Isotretinoin is a synthetic form of Vitamin A which effects the growth of normal cells and cancer cells
Participants participating in this study will receive a combination of alpha-interferon and isotretinoin Alpha-interferon will be given once a day for an initial period of 12 weeks Participants will take the drug home where a nurse or family member of the participant who can be trained at UTMDACC will inject it just under the skin SQ Isotretinoin will be given by mouth twice a day
If a participants disease does not show a response the alpha-interferon and the isotretinoin will be increased If side effects occur the dose of alpha-interferon andor isotretinoin will be decreased by 50 If the side effects are severe therapy will be discontinued If the participants disease is unresponsive or worsens the participant will be taken off study and other treatments will be recommended
Responding participants will be placed on a maintenance schedule for as long as they respond Up to 60 participants will be studied at UT MD Anderson Cancer Center to test the effectiveness of this drug combination
This is an investigational study Alpha-interferon and isotretinoin are FDA approved and commercially available
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