Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
Drug: Isotretinoin (Accutane)
Drug: Interferon Alpha
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies|
- To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies. [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
|Study Start Date:||May 1990|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Alpha-interferon + Isotretinoin
Drug: Isotretinoin (Accutane)
0.5 mg/k (1.0 mg/k total) by mouth twice a day
Other Name: 13-cis-Retinoic AcidDrug: Interferon Alpha
Starting dose of 3 MU injected under skin once a day for 12 weeks.
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 participant's disease does not show a response, the alpha-interferon and the isotretinoin will be increased. If side effects occur, the dose of alpha-interferon and/or isotretinoin will be decreased by 50%. If the side effects are severe, therapy will be discontinued. If the participant's 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 M.D. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038376
|United States, Texas|
|M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Razelle Kurzrock, MD, BS||UT MD Anderson Cancer Center|