Methods for treating cancers using polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione

Abstract

Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

1 - 32 . (canceled) 
     
     
         33 . A method of treating a blood-borne tumor, which comprises administering to a patient having the blood-borne tumor a therapeutically effective amount of a hydrated crystalline form of 3-(4-amino-l-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione. 
     
     
         34 . The method of  claim 33 , wherein the crystalline form is a hemihydrate. 
     
     
         35 . The method of  claim 34 , wherein the crystalline form has an X-ray powder diffraction pattern comprising peaks at approximately 16, 22 and 27 degrees 2θ. 
     
     
         36 . The method of  claim 35 , wherein the X-ray powder diffraction pattern further comprises a peak at approximately 18 degrees 2θ. 
     
     
         37 . The method of  claim 34 , wherein the crystalline form has differential scanning calorimetry thermogram comprising endotherms with maxima at about 146° C. and about 268° C. 
     
     
         38 . The method of  claim 34 , wherein the crystalline form exhibits a mass loss of about 3.1% of its total mass when heated to about 175° C. 
     
     
         39 . The method of  claim 34 , wherein the blood-borne tumor is myeloma, lymphoma, or leukemia. 
     
     
         40 . The method of  claim 39 , wherein the myeloma is multiple myeloma, smoldering myeloma, or indolent myeloma. 
     
     
         41 . The method of  claim 40 , wherein the multiple myeloma is relapsed multiple myeloma, refractory multiple myeloma, or newly diagnosed multiple myeloma. 
     
     
         42 . The method of  claim 39 , wherein the lymphoma is non-Hodgkin's lymphoma, Hodgkin's lymphoma, cutaneous T-Cell lymphoma, cutaneous B-Cell lymphoma, diffuse large B-Cell lymphoma, or low grade follicular lymphoma. 
     
     
         43 . The method of  claim 39 , wherein the lymphoma is non-Hodgkin's lymphoma. 
     
     
         44 . The method of  claim 39 , wherein the leukemia is myeloblastic leukemia or myelogenous leukemia. 
     
     
         45 . The method of  claim 34 , wherein the therapeutically effective amount is about 5 mg, 10 mg, 15 mg, or 25 mg. 
     
     
         46 . The method of  claim 34 , wherein the crystalline form is administered orally. 
     
     
         47 . The method of  claim 34 , wherein the crystalline form is administered in a capsule. 
     
     
         48 . The method of  claim 34 , wherein the crystalline form is administered in a tablet. 
     
     
         49 . The method of  claim 34 , wherein the crystalline form is substantially pure. 
     
     
         50 . The method of  claim 33 , wherein the crystalline form has an X-ray powder diffraction pattern comprising peaks at approximately 27 and 28 degrees 2θ. 
     
     
         51 . The method of  claim 50 , wherein the crystalline form has a differential scanning calorimetry curve comprising endotherms with maxima at about 122° C. and about 270° C. 
     
     
         52 . The method of  claim 50 , wherein the blood-borne tumor is myeloma, lymphoma, or leukemia. 
     
     
         53 . The method of  claim 52 , wherein the myeloma is multiple myeloma, smoldering myeloma, or indolent myeloma. 
     
     
         54 . The method of  claim 53 , wherein the multiple myeloma is relapsed multiple myeloma, refractory multiple myeloma, or newly diagnosed multiple myeloma. 
     
     
         55 . The method of  claim 52 , wherein the lymphoma is non-Hodgkin's lymphoma, Hodgkin's lymphoma, cutaneous T-Cell lymphoma, cutaneous B-Cell lymphoma, diffuse large B-Cell lymphoma, or low grade follicular lymphoma. 
     
     
         56 . The method of  claim 52 , wherein the lymphoma is non-Hodgkin's lymphoma. 
     
     
         57 . The method of  claim 52 , wherein the leukemia is myeloblastic leukemia or myelogenous leukemia. 
     
     
         58 . The method of  claim 50 , wherein the therapeutically effective amount is about 5 mg, 10 mg, 15 mg, or 25 mg. 
     
     
         59 . The method of  claim 50 , wherein the crystalline form is administered orally. 
     
     
         60 . The method of  claim 50 , wherein the crystalline form is administered in capsule. 
     
     
         61 . The method of  claim 50 , wherein the crystalline form is administered in a tablet. 
     
     
         62 . The method of  claim 50 , wherein the crystalline form is substantially pure.