PHASE Ia/ Ib STUDY OF CHIMERIC FIBRIL-REACTIVE MONOCLONAL ANTIBODY 111F4 IN PATIENTS WITH AL AMYLOIDOSIS

Protocol: 
AAAM5108
Phase: 
I

PHASE Ia/ Ib STUDY OF CHIMERIC FIBRIL-REACTIVE MONOCLONAL ANTIBODY 111F4 IN PATIENTS WITH AL AMYLOIDOSIS

Presently, treatment of patients with AL amyloidosis is limited to reducing production of the amyloid-forming light-chain protein by giving conventional or high-dose (with stem cell transplant) anti-plasma cell chemotherapy, as used for patients with multiple myeloma. Although this approach has extended survival, the prognosis remains poor due to the persistence or progression of the amyloid deposits in vital organs, such as the heart or kidney. A different treatment strategy would be to eliminate these deposits by administration of the anti-amyloid monoclonal antibody 11-1F4, that has been shown in an experimental animal model of amyloidosis to destroy this material. This encouraging research result has led to production by the National Cancer Institute’s Biological Resource Branch of a form of antibody 11-1F4 that can be given to patients with AL amyloidosis. To administer any investigational drugs in humans (antibodies, etc.), the Federal Drug Administration (FDA) requires a Phase I study to determine the safety, as well as the maximum dose that can be tolerated. In this regard, the FDA has granted an Investigational New Drug (IND) permit that will allow Dr. Lentzsch to conduct a Phase Ia/b clinical trial of monoclonal antibody 11-1F4 in patients with AL amyloidosis. As required by the approved protocol, the phase1a part study will involve seven groups of three to six patients each (up to 4221 total individuals). The first group of 3 will receive the starting dose of the antibody and, if tolerated, the following 6 groups will each receive (if tolerated) progressively higher doses of the antibody. Patients in part 1a of the trial will receive only one treatment. It is estimated that the trial can be completed in 6 to 8 months. Once the maximal tolerated dosage is established during the phase 1a part additional 10 patients will be accrued to the part 1b part of the trial and treated at the maximal tolerated dosage. Those patients will receive 4 weekly treatments within 4 weeks. Patients who are treated in the part 1a of the trial and showed no toxicity can be also treated in the part 1b of the trial.

Are you Eligible? (Inclusion Criteria)

• Patients must have a confirmed diagnosis of AL amyloidosis based on accepted clinical and laboratory criteria
• Patients are at least 21 years old.
• Patients have measurable, localized amyloid masses in certain organs or have clinically evident systemic disease in certain organs.
• Patients have received at least one previous therapy for their amyloidosis, after which their disease returned. If they did not have previous treatment, then they must have either declined or were not eligible for a stem cell transplant, or any other life-prolonging or life-saving procedure.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States