Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
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|ClinicalTrials.gov Identifier: NCT00038376|
Recruitment Status : Completed
First Posted : May 31, 2002
Last Update Posted : October 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, T-Cell Mycosis Fungoides Hematologic Neoplasms||Drug: Isotretinoin (Accutane) Drug: Interferon Alpha||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies|
|Actual Study Start Date :||May 8, 1990|
|Actual Primary Completion Date :||June 30, 2005|
|Actual Study Completion Date :||June 30, 2005|
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 Acid
Drug: Interferon Alpha
Starting dose of 3 MU injected under skin once a day for 12 weeks.
- To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies. [ Time Frame: 15 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|