Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

Gilead Sciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Pancreatic Neoplasms

Treatments

Drug: hMN14 (labetuzumab)

Study type

Interventional

Funder types

Industry

Identifiers

IM-T-hMN14-03

Details and patient eligibility

About

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of pancreatic cancer.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Disease Characteristics:

Patients with a documented histologic or cytologic diagnosis of a pancreatic malignancy
Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
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.
Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
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.

Patient Characteristics/Inclusion Criteria:

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.