Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00041639
First received: July 11, 2002
Last updated: June 23, 2005
Last verified: January 2004
  Purpose

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


Condition Intervention Phase
Pancreatic Neoplasms
Drug: hMN14 (labetuzumab)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Estimated Enrollment: 75
Study Start Date: January 2000
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041639

Locations
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
Germany
Medizinische Fakultaet der Charité Berlin
Berlin, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Hungary
Semmelweis University
Budapest, Hungary
Medical University of Szeged
Szeged, Hungary
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William Wegener, MD Immunomedics, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00041639     History of Changes
Other Study ID Numbers: IM-T-hMN14-03
Study First Received: July 11, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 22, 2014