Adequate blood coagulation function Acceptable coagulation profile Adequate coagulation function Normal coagulation profile Adequate coagulation functioning within days prior to study registration defined by either of the following criteria: Normal coagulation panel. Have acceptable coagulation parameters defined as: Adequate coagulation function Adequate coagulation profile. Adequate coagulation profile: Have adequate coagulation functioning within days prior to start of study treatment, defined by either of the following criteria: Hematologic (Coagulation Factors): Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study) Clinically significant coagulation disorder No history of a coagulation disorder Hepatic insufficiency not due to tumor resulting in clinical jaundice or bilirubin >. x ULN and/or coagulation defects Clinically apparent jaundice and/or known coagulation defects Hematologic (Coagulation Factors): Have adequate coagulation function. Acceptable coagulation profile Abnormal coagulation parameters Coagulation function tests not suggestive of severe liver dysfunction Coagulation: Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects Abnormal and clinical significant coagulation parameters at the discretion of the Investigator, i.e.: Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for additional liver function tests and coagulation parameters are not required for entry into this protocol Known past or current coagulation defects. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Adequate coagulation function Adequate hematologic, organ, and coagulation within weeks ( days) prior to randomization. Adequate coagulation functioning within days prior to registration for protocol therapy defined by either of the following criteria: Adequate coagulation Adequate coagulation parameters (within days prior to registration) Have adequate coagulation functioning within days prior to start of study treatment, defined by either of the following criteria: Coagulation Normal coagulation panel. Normal coagulation profile as evidenced by PT and aPTT ? . x ULN; Normal Coagulation profile. Congenital coagulation abnormalities Normal platelet count and coagulation profile Adequate coagulation function as defined by the following criteria: Adequate coagulation status History or suspicion of a congenital or acquired coagulation disorder. Known past or current coagulation defects. Coagulation status: for intratumoral cohort, coagulation profile favorable to surgery Thrombocytopenia (platelet count < K) or coagulation disorder that would contraindicate intramuscular injection History of bleeding/coagulation problems Adequate coagulation defined as: