A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Advanced/Metastatic Pancreatic Carcinoma

Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

Sponsors

Lead sponsor: Immunomedics, Inc.

Source Immunomedics, Inc.
Brief Summary

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

Overall Status Completed
Start Date January 2000
Completion Date December 2003
Phase Phase 1/Phase 2
Study Type Interventional
Enrollment 75
Condition
Intervention

Intervention type: Drug

Intervention name: hMN14 (labetuzumab)

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
William Wegener, MD Study Chair Immunomedics, Inc.
Location
facility
Hoag Cancer Center | Newport Beach, California, 92658, United States
Washington Hospital Center | Washington, District of Columbia, 20010, United States
Bay Pines VA Medical Center | St. Petersburg, Florida, 33744, United States
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania, 15213, United States
Virginia Mason Medical Center | Seattle, Washington, 98101-2799, United States
Medizinische Fakultaet der Charité Berlin | Berlin, Germany
Universitaetsklinikum Leipzig | Leipzig, Germany
Semmelweis University | Budapest, Hungary
Medical University of Szeged | Szeged, Hungary
Academic Medical Center | Amsterdam, Netherlands
Location Countries

Germany

Hungary

Netherlands

United States

Verification Date

January 2004

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov