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Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies | Clinical Trials | Clareo Health

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

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

NCT00038376•M.D. Anderson Cancer Center

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Exclusion Criteria

•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.
+3 more criteria

Locations (1)

M. D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

May 8, 1990

Primary Completion Date

June 30, 2005

Completion Date

June 30, 2005

Last Updated

October 29, 2018

Enrollment

ACTUAL participants

Conditions

Lymphoma, T-CellMycosis FungoidesHematologic Neoplasms

Interventions

Isotretinoin (Accutane)

DRUG

Interferon Alpha

DRUG

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RECRUITING

Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Exclusion Criteria

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

MB-105 in Patients With CD5 Positive T-cell Lymphoma