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 cancer which comprises administering to a patient having a cancer a therapeutically effective amount of a crystalline form of 3-(4-amino-1-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  0 , wherein the crystalline form has an X-ray powder diffraction pattern comprising a peak at approximately 27 degrees 2θ. 
     
     
         36 . The method of  claim 35 , wherein the pattern further comprises peaks at approximately 16, 18 and 22 degrees 2θ. 
     
     
         37 . The method of  claim 33 , wherein the crystalline form has a differential scanning calorimetry curve exhibiting endotherms at about 146° C. and about 268° C. 
     
     
         38 . The method of  claim 33 , wherein the crystalline form is a hemisolvate. 
     
     
         39 . The method of  claim 38 , wherein the crystalline form has an X-ray powder diffraction pattern comprising a peak at approximately 25 degrees 2θ. 
     
     
         40 . The method of  claim 39 , wherein the pattern further comprises a peak at approximately 15.5 degrees 2θ. 
     
     
         41 . The method of  claim 38 , wherein the crystalline form has a differential scanning calorimetry curve exhibiting endotherms at about 150° C. and about 269° C. 
     
     
         42 . The method of  claim 33 , wherein the crystalline form is a solvate. 
     
     
         43 . The method of  claim 42 , wherein the crystalline form has an X-ray powder diffraction pattern comprising a peak at approximately 28 degrees 2θ. 
     
     
         44 . The method of  claim 43 , wherein the pattern further comprises a peak at approximately 27 degrees 2θ. 
     
     
         45 . The method of  claim 42 , wherein the crystalline form has a differential scanning calorimetry curve exhibiting endotherms at about 122° C. and about 270° C. 
     
     
         46 . The method of  claim 33 , wherein the crystalline form is a dihydrate. 
     
     
         47 . The method of  claim 46 , wherein the crystalline form has an X-ray powder diffraction pattern comprising a peak at approximately 20 degrees 2θ. 
     
     
         48 . The method of  claim 47 , wherein the pattern further comprises peaks at approximately 24.5 and 29 degrees 2θ. 
     
     
         49 . The method of  claim 46 , wherein the crystalline form has a differential scanning calorimetry curve exhibiting endotherms at about 99° C. and about 269° C. 
     
     
         50 . The method of  claim 33 , wherein the crystalline form is a hydrate. 
     
     
         51 . The method of  claim 50 , wherein the crystalline form has an X-ray powder diffraction pattern comprising a peak at approximately 15 degrees 2θ. 
     
     
         52 . The method of  claim 51 , wherein the pattern further comprises peaks at approximately 26 and 31 degrees 2θ. 
     
     
         53 . The method of  claim 50 , wherein the crystalline form has a differential scanning calorimetry curve exhibiting an endotherm between about 50° C. and about 125° C. and an endotherm about 269° C. 
     
     
         54 . The method of any one of  claims 33  to  53 , wherein the crystalline form is substantially pure. 
     
     
         55 . The method of any one of  claims 33  to  53 , wherein the cancer is multiple myeloma. 
     
     
         56 . The method of any one of  claims 33  to  53 , wherein the cancer is melanoma. 
     
     
         57 . The method of any one of  claims 33  to  53 , wherein the cancer is prostate cancer. 
     
     
         58 . The method of any one of  claims 33  to  53 , wherein the cancer is ovarian cancer. 
     
     
         59 . The method of any one of  claims 33  to  53 , wherein the cancer is a cancer of the blood. 
     
     
         60 . The method of any one of  claims 33  to  53 , wherein the cancer is leukemia. 
     
     
         61 . The method of any one of  claims 33  to  53 , wherein the cancer is myelogenous leukemia. 
     
     
         62 . The method of any one of  claims 33  to  53 , wherein the cancer is non-hodgkin's lymphoma. 
     
     
         63 . The method of any one of  claims 33  to  53 , wherein the cancer is pancreatic cancer. 
     
     
         64 . The method of any one of  claims 33  to  53 , wherein the cancer is renal cancer. 
     
     
         65 . The method of any one of  claims 33  to  53 , wherein the crystalline form is administered in an amount of from about 0.1 to about 150 mg per day. 
     
     
         66 . The method of any one of  claims 33  to  53 , wherein the crystalline form is administered orally. 
     
     
         67 . The method of any one of  claims 33  to  53 , wherein the crystalline form is administered in a dosage form of a capsule or a tablet.