Radioimmunotherapy of lymphoma using anti-CD20 antibodies

• US 6,565,827 B1
• Filed: 08/07/2001
• Issued: 05/20/2003
• Est. Priority Date: 09/16/1993
• Status: Expired due to Fees

• Current Assignee: GlaxoSmithKline LLC (GlaxoSmithKline PLC)
• Original Assignee: Coulter Pharmaceutical, Inc. (GlaxoSmithKline PLC), Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Kaminski, Mark S., Wahl, Richard L., Butchko, Gregory M., Glenn, Stephan D.
• Primary Examiner(s): Hartley, Michael G.
• Application Number:
  US09/924,360
• Time in Patent Office: 651 Days
• Field of Search: 424/1.49, 424/1.69, 424/1.53, 424/174.1, 424/144.1, 424/133.1, 424/130.1, 424/179.1, 424/172.1, 424/178.1, 530/391.3, 530/391.5, 530/388.73
• US Class Current: 424/1.49
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 51/1069 the tumor cell being from blood cells, e.g. the cancer being a myeloma
• CPC Class Codes: C07K 14/52 Cytokines; Lymphokines; Interferons
• CPC Class Codes: C07K 16/22 against growth factors ; against growth regulators
• CPC Class Codes: C07K 16/2887 against CD20
• CPC Class Codes: C07K 2317/73 Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
• CPC Class Codes: C07K 2319/00 Fusion polypeptide
• CPC Class Codes: G01N 33/57426 leukemia

Abstract

Methods for the treatment of lymphoma by administration of a B cell-specific antibody are described. The invention encompasses providing to a patient both unlabeled antibodies and antibodies labeled with a radioisotope. A principal advantage of the method is that tumor responses can be obtained in a radiometric dose range that does not require hematopoietic stem cell replacement as an adjunct therapy.

Claims

1. A composition, comprising:

(1) a radioactively labeled monoclonal antibody or radioactively labeled monoclonal antibody fragment in an amount providing 13 to 150 mCi of radioactivity and providing irradiation in a dose range of 10 to 200 cGy to the whole body of a human patient, said amount being effective for achieving remission of B-cell lymphoma in the patient, wherein said antibody or said antibody fragment binds to CD20 antigen present on the surface of cells of B-cell lymphoma, wherein the amount of radioactivity that labels the antibody or antibody fragment is less than the amount which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells into said patient in order for the patient to recover hematopoietic function, and wherein said radioactively is provided by ⁹⁰Y, and

(2) a pharmaceutically acceptable carrier.

2. The composition of claim 1, wherein said amount of radioactivity is 13 to 50 mCi.

3. The composition of claim 2, wherein said remission is a partial remission.

4. The composition of claim 2, wherein said remission is a complete remission.

5. The composition of claim 1, wherein said amount of radioactivity is 20 to 50 mCi.

6. The composition of claim 1, wherein the antibody or antibody fragment binds to a binding site on said CD20 antigen that is recognized by a B1 antibody.