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

Sponsor:	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Interferon alfa-2a Interferon alfa-2b Interferon alfa-n1 Tretinoin Isotretinoin Interferons

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies. [ Time Frame: 15 Years ] [ Designated as safety issue: No ]

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
Experimental: 1 Alpha-interferon + Isotretinoin	Drug: Isotretinoin (Accutane) 0.5 mg/k (1.0 mg/k total) by mouth twice a day Other Name: 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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

1) Pediatric Patients under 18 years old.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038376

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Razelle Kurzrock, MD, BS

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Razelle Kurzrock, MD, BS/Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038376 History of Changes
Other Study ID Numbers:	DM90-007
Study First Received:	May 30, 2002
Last Updated:	March 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

Neoplasms
Lymphoma
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Neoplasms by Site
Hematologic Diseases

Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Tretinoin
Isotretinoin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012