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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038376 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, T-Cell Mycosis Fungoides Hematologic Neoplasms |
Drug: Isotretinoin (Accutane) Drug: Interferon Alpha |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 1990 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Alpha-interferon + Isotretinoin
|
Drug: Isotretinoin (Accutane)
0.5 mg/k (1.0 mg/k total) by mouth twice a day
Drug: Interferon Alpha
Starting dose of 3 MU injected under skin once a day for 12 weeks.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Exclusion Criteria:
1) Pediatric Patients under 18 years old.
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Razelle Kurzrock, MD, BS | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Razelle Kurzrock, MD, BS/Professor ) |
| Study ID Numbers: | DM90-007 |
| Study First Received: | May 30, 2002 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00038376 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
T-cell lymphoma accutane isotretinoin mycosis fungoides T-cell malignancies |
|
Interferon-alpha Interferon Type I, Recombinant Immunoproliferative Disorders Immunologic Factors Hematologic Neoplasms Hematologic Diseases Interferons Sezary Syndrome Mycosis Fungoides Angiogenesis Inhibitors Antiviral Agents Mycoses |
Lymphatic Diseases Cutaneous T-cell Lymphoma Lymphoma, T-Cell Isotretinoin Tretinoin Interferon Alfa-2a Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Interferon Alfa-2b Lymphoma Lymphoma, T-Cell, Cutaneous |
|
Anti-Infective Agents Interferon Type I, Recombinant Hematologic Neoplasms Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Sezary Syndrome Mycosis Fungoides Mycoses Neoplasms by Site Therapeutic Uses Lymphoma, T-Cell Isotretinoin Growth Inhibitors Angiogenesis Modulating Agents |
Dermatologic Agents Lymphoma Interferon-alpha Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Growth Substances Interferons Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Lymphoproliferative Disorders |
