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Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00041639
Recruitment Status : Completed
First Posted : July 15, 2002
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: hMN14 (labetuzumab) Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2000
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041639

United States, California
Hoag Cancer Center
Newport Beach, California, United States, 92658
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Bay Pines VA Medical Center
St. Petersburg, Florida, United States, 33744
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101-2799
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
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: William Wegener, MD Immunomedics, Inc.
More Information

ClinicalTrials.gov Identifier: NCT00041639     History of Changes
Other Study ID Numbers: IM-T-hMN14-03
First Posted: July 15, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2004

Keywords provided by Immunomedics, Inc.:
Pancreatic Cancer
Pancreatic Carcinoma
Pancreatic Neoplasms
Pancreas Cancer
Pancreatic Tumor

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases