Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, T-Cell; Mycosis Fungoides; Hematologic Neoplasms
Intervention: Accutane (Drug); Interferon Alpha (Drug)
Phase: Phase 2
Sponsored by: M.D. Anderson Cancer Center
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
Official title: Phase 2 Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Histologic proof of incurable T-Cell malignancy and not eligible for existing higher
- Patients should not have received chmoe, immuno, hormonal, or radiation therapy within
3 weeks of entry into this study and must have recovered from acute toxic effects of
- Life expectancy of at least 12 weeks and a ZUBROD status of =2.
- Signed informed consent.
- Measurable or evaluable disease.
- >/= 18 years of age.
- No other current chemo, immuno, or radiotherapy allowed.
- Bilirubin =2 AND SGPT =4X upper limits of normal.
- Serum creatinine =2.
- Serum triglyceride level =2. 5X upper limits of normal.
- Patients may not have serious intercurrent medical illness.
- Patients of childbearing potential must practice adequate contraception.
- Patients will eligible regardless of the extent of prior chemotherapy.
Locations and Contacts
M. D. Anderson Cancer Center, Houston, Texas 77030, United States
Official website for M. D. Anderson Cancer Center
Starting date: May 1990
Last updated: August 11, 2005