Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, T-Cell; Mycosis Fungoides; Hematologic Neoplasms
Intervention: Isotretinoin (Accutane) (Drug); Interferon Alpha (Drug)
Phase: Phase 2
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Razelle Kurzrock, MD, BS, Principal Investigator, Affiliation: UT MD 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 II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling 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
Minimum age: 18 Years.
Maximum age: N/A.
1. Patients with histologic proof of incurable T-cell malignancy or Hodgkin's disease,
and not eligible for existing/higher priority protocols. Patients with Hodgkin's
disease will be eligible only if they have failed at least a MOPP-like and ABVD-like
2. Patients should not have received chemotherapy, immunotherapy, hormonal therapy, or
radiation therapy within three weeks of entry into the study and must have recovered
from acute toxic effects of prior therapy.
3. Patients must have a life expectancy of at least 12 weeks and a performance status of
less than or equal to 2 (Zubrod scale: Appendix A).
4. Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study, in keeping with policies of the hospital. The
only approved consent form is appended to this protocol.
5. Patients must have measurable or evaluable disease.
6. Patients must be greater than or equal to 18 years old.
7. Patients may receive no other concurrent chemotherapy, immunotherapy, or
8. Patients should have adequate hepatic function with bilirubin of less than or equal
to 2. 0 mg%, and SGPT of less than or equal to 4 times the upper limits of normal.
9. Patients should have adequate renal function (defined as serum creatinine of less
than or equal to 2. 0 mg%).
10. Patients should have serum triglyceride level less than or equal to 2. 5 times the
upper limits of normal.
11. Patients may not have serious intercurrent medical illness.
12. Patients of child bearing potential must be practicing adequate contraception.
13. Patients will be eligible regardless of the extent of prior chemotherapy.
1) Pediatric Patients under 18 years old.
Locations and Contacts
M. D. Anderson Cancer Center, Houston, Texas 77030, United States
UT MD Anderson Cancer Center website
Starting date: May 1990
Last updated: July 27, 2012