Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

HTLV stands for human T cell leukemia virus. HTLV-1 is a virus that attacks specific kinds of white blood cells called T cells. T cells are part of the natural defense system of the body. HTLV-1 has been associated with leukemia and lymphoma. In addition, approximately 1% of all patients infected with HTLV-1 develops a condition known as HTLV-1 associated myelopathy (HAM) / tropical spastic paraparesis (TSP).

Currently there is no clearly defined, effective treatment for patients with HAM/TSP. Steroids have been used as therapy but have only been able to provide temporary relief of symptoms. Human interferon is a small protein released from different kinds of cells in the body. Interferon has been known to have antiviral and immunological effects and has been used to treat hepatitis and multiple sclerosis. Interferon Beta is released from cells called fibroblasts. These cells play a role in the production of connective tissue.

The purpose of this study is to evaluate the possible role of recombinant interferon beta (Avonex) in treatment of HAM/TSP. The study is broken into three phases, a pre-treatment phase, a treatment phase, and a post-treatment phase. The total duration of the study will be 44 weeks.

Patients participating in this study will receive injections of Avonex 1 to 2 times a week. Throughout the study patients will regularly submit blood samples and undergo diagnostic tests such as MRI and measures of somatosensory evoked potentials.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

INCLUSION CRITERIA:

patients entering this study will:

be at least 16 years old;

meet diagnostic criteria for HAM/TSP as defined by the WHO and current literature;

have progression of the clinical symptoms during the past 12 months;

have an EDSS of less than or equal to 7;

have spontaneous in vitro lymphoproliferation;

able to provide written informed consent;

able to comply with protocol requirements;

if a females, be not of a child bearing potential or if of child bearing potential documented to be non-pregnant by urine pregnancy test with adequate counseling and contraception.

EXCLUSION CRITERIA:

Patients entering this study will not:

be pregnant or lactating;

be HIV, HCV, or hepatitis B surface antigen positive;

have a significant medical condition that in the opinion of the investigator would compromise the safety of the patient;

have a history of suicidal ideations and no major depressive event (DSM-IV) within 3 months of enrollment;

have used an investigational medication or steroids within 90 days of the enrollment visit;

have a history of an allergic reaction to albumin;

have metallic fragments, ferromagnetic surgical clips, and implanted electronic devices (cardiac pace makers, vagal nerve stimulators);

drug abuse.