| Exclusion Criteria: | 1) Known central nervous system (CNS) tumor involvement.
2) Evidence of other active malignancy requiring treatment.
3) Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
4) ECG demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
5) Active serious systemic disease, excluding the patient's current cancer diagnosis, such as a bacterial or fungal infection, that would prevent the patient from participating in this treatment trial.
6) History of HIV infection.
7) Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
8) Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
9) Long term maintenance of first remission by taxane or other chemotherapeutic agent(s). Hormone therapy is permissible but must be discontinued at least 4 weeks prior to study entry.
10) Surgery for secondary cytoreduction. Subjects who underwent interval cytoreductive surgery followed by adjuvant chemotherapy are eligible pending approval by the study sponsor prior to the subject receiving the first dose of MORAb-003.
11) Initiation or planned initiation of cancer therapy not given to induce primary remission. Substitutions of agents materially similar to those used in the original regimen are permissible.
12) Breast-feeding, pregnant, or likely to become pregnant during the study. |