Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Disease Characteristics:
Patients with a documented histologic or cytologic diagnosis of a pancreatic malignancy
Performance Status: Patients with a Karnofsky performance status \> 70% (or equivalent, ECOG 0-1) and an expected survival rate of at least 3 months
Hematopoietic: Hemoglobin \> 10g/dL; WBC \> 3000 per mm3; Granulocyte count \> 1500 per mm3; platelet count \> 100,000 per mm3
Hepatic: Total bilirubin \< 1.5 times the institutional upper limit of normal (IULN); AST or ALT \< 2 X IULN
Renal: Creatinine \< IULN
Cardiovascular: Patients with LVEF \>/= 50% by required MUGA/2D-ECHO study
Pulmonary: Patients with DF and FEV1 \>/= 60 % by required Pulmonary Function Tests
Gastrointestinal:Patients with severe anorexia or other related symptomology are excluded
Central Nervous System: Patient with known metastatic disease to the CNS are excluded
Other: Patients who have had a prior imaging study with a murine antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
You may not be if
Patients with at least one identified (confirmed) and measureable tumor site.
Prior/Concurrent Therapy:
Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN14 IgG (i.e., HAHA)
Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver; 2,000 cGy for the lungs and kidneys).
Other: Any experimental therapy (i.e., drugs, biologics, procedures) for the primary malignancy, either during or within four weeks prior to study entry.
Clareo Health | Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer