CompletedNCT00038376Updated Oct 29, 2018

Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies

A Phase 2 interventional study of Isotretinoin (Accutane) and Interferon Alpha in Lymphoma, T-Cell, Mycosis Fungoides and Hematologic Neoplasms, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-29.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 12 years after the study started (first participant enrolled May 1990, registered May 2002).

Phase: Phase 2
Study type: Interventional
Enrollment: 56
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

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 (Accutane).

Read the detailed description

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.

Conditions studied

Lymphoma, T-Cell
Mycosis Fungoides
Hematologic Neoplasms

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Keywords

T-cell lymphoma
accutane
isotretinoin
mycosis fungoides
T-cell malignancies

In context

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 56 is above the median of 46 across 358 interventional studies indexed under Mycoses.

Browse Mycoses studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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 regimen.
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.
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).
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.
Patients must have measurable or evaluable disease.
Patients must be greater than or equal to 18 years old.
Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy.
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.
Patients should have adequate renal function (defined as serum creatinine of less than or equal to 2.0 mg%).
Patients should have serum triglyceride level less than or equal to 2.5 times the upper limits of normal.
Patients may not have serious intercurrent medical illness.
Patients of child bearing potential must be practicing adequate contraception.
Patients will be eligible regardless of the extent of prior chemotherapy.

Exclusion criteria

Exclusion Criteria:

Pediatric Patients under 18 years old.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 56 participants (actual)

Study arms

Experimental
1
Alpha-interferon + Isotretinoin
Drug: Isotretinoin (Accutane) · Drug: Interferon Alpha

Interventions

DrugIsotretinoin (Accutane)
0.5 mg/k (1.0 mg/k total) by mouth twice a day
Also known as: 13-cis-Retinoic Acid
DrugInterferon Alpha
Starting dose of 3 MU injected under skin once a day for 12 weeks.
Also known as: Intron A, Interferon alfa-2b

What researchers measure

Primary outcomes

To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies.
Time frame: 15 Years

Study locations

1 site

M. D. Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00038376
Lead sponsor: M.D. Anderson Cancer Center
Responsible party: Sponsor
First posted: May 31, 2002
Start date: May 8, 1990
Primary completion: Jun 30, 2005
Completion: Jun 30, 2005
Last update: Oct 29, 2018

Study contacts

Razelle Kurzrock, MD, BS

principal investigator · UT MD Anderson Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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