| Exclusion Criteria: | 1) Received any investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer.
2) History of receiving murine or human/murine recombination rpoducts, such as G250, BE-8 and other monoclonal antibodies. This exclusion will be evaluated by the Centocor medical monitor for Castleman's Disease subjects. (Note: prior rituximab treatment is not an exlcusion criterion.) For Cohort 7, subjects refractory to specific IL-6 or IL-6 receptor antagonists.
3) Serious concurrent illness or significant cardiac disease characterized by signficiant ischemic coronary disease or congestive heart failure
4) Clinically significant infection that is chronic, recurrent, or active.
5) Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening) or having received an allogeneic bone marrow transplant or an allogeneic peripheral blood stem cell transplant
6) Central nervous system (CNS) metastatic disease
7) Concomitant or prior malignancy (other than the one under study) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has been disease-free for greater than or equal to 3 years
8) Any other concomitant immunotherapy, biotherapy, treatment with G-CSF (or GM-CSF), radiotherapy, chemotherapy, investigative therapy, or immunosuppressive therapy. Exception: Castleman's Disease; daily maintenance dose of prednisone of up to 1 mg/kg or the equivalent will be allowed and providing no change has been made to the dosage within 4 weeks of first dose of study drug.
9) Planned surgery (except for minor surgical procedures) during study period
10) Pregnant or lactating women
11) Known HIV seropositivity; known HIV, hepatitis B or hepatitis C infection. For Cohort 7, known human herpesvirus-8 (HHV-8) seropositivity.
12) Autoimmune disease (e.g., inflammatory bowel disease such as Crohn's disease, systemic lupus,multiple sclerosis)
13) Any uncontrolled medical condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk by participating in the study or confounds ability to interpret data from the study.
14) Vaccinated with live, attenuated vaccines within 4 weeks of the first administratino of CNTO 328. Inactivated injectable influenza vaccine is permitted. |