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Sponsors and Collaborators: |
Mayo Clinic Scottsdale National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00588822 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block abnormal cell growth in different ways. Some block the ability of abnormal cells to grow and spread. Others find abnormal cells and help kill them or carry cell-killing substances to them.
PURPOSE: This phase II trial is studying how well rituximab works in treating patients with peripheral neuropathy caused by monoclonal gammopathy of undetermined significance.
Condition | Intervention | Phase |
---|---|---|
Precancerous/Nonmalignant Condition |
Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Rituximab for Peripheral Neuropathy Associated With Monoclonal Gammopathy of Undetermined Significance (MGUS) |
Estimated Enrollment: | 41 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients with neuropathy progression at 6 months (as indicated by an increase in the Neuropathy Impairment Score [NIS] of ≥ 10 or a modified Rankin Score increase of > 1 grade) are taken off study. Patients with stable or responding neuropathy (NIS of < 10 or a modified Rankin Score increase of < 1 grade) receive a second course of rituximab. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 6 months.
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), as evidenced by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Inclusion Criteria:
Fertile patients must use an acceptable method of birth control during treatment and for 6 months after completion of treatment
No history of psychiatric disorder requiring hospitalization, psychiatric consultation, or psychotropic medications within the last year
Patients with controlled depression are eligible, as defined by the following:
Exclusion criteria:
History or serological profile suggesting prior hepatitis B virus (HBV) infection (i.e., HbsAg or anti-HBs with anti-HBc)
Confirmed diagnosis of systemic lupus erythematosus (SLE)
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Principal Investigator: | Benn E. Smith, MD | Mayo Clinic Scottsdale |
Study ID Numbers: | CDR0000581084, MAYO-IRB-119104 |
Study First Received: | December 20, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00588822 |
Health Authority: | Unspecified |
monoclonal gammopathy of undetermined significance |
Immunoproliferative Disorders Neuromuscular Diseases Precancerous Conditions Rituximab Hematologic Diseases |
Blood Protein Disorders Peripheral Nervous System Diseases Monoclonal Gammopathies, Benign Paraproteinemias Monoclonal gammopathy of undetermined significance |
Neoplasms Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Hypergammaglobulinemia Antirheumatic Agents Pharmacologic Actions |