Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies.
Razelle Kurzrock, MD, BS
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|M. D. Anderson Cancer Center||Houston, Texas 77030|