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

October 25, 2018 updated by: M.D. Anderson Cancer Center

Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  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 regimen.
  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 radiotherapy.
  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.

Exclusion Criteria:

1) Pediatric Patients under 18 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Alpha-interferon + Isotretinoin
Drug: Isotretinoin (Accutane)
0.5 mg/k (1.0 mg/k total) by mouth twice a day
Other Names:
  • 13-cis-Retinoic Acid
Drug: Interferon Alpha
Starting dose of 3 MU injected under skin once a day for 12 weeks.
Other Names:
  • Intron A
  • Interferon alfa-2b

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Razelle Kurzrock, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 8, 1990

Primary Completion (ACTUAL)

June 30, 2005

Study Completion (ACTUAL)

June 30, 2005

Study Registration Dates

First Submitted

May 30, 2002

First Submitted That Met QC Criteria

May 30, 2002

First Posted (ESTIMATE)

May 31, 2002

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM90-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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