Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
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
1 other identifier
interventional
75
4 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2000
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
July 11, 2002
CompletedFirst Posted
Study publicly available on registry
July 15, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedAugust 19, 2021
January 1, 2004
July 11, 2002
August 12, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (10)
Hoag Cancer Center
Newport Beach, California, 92658, United States
Washington Hospital Center
Washington D.C., 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Wegener, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 11, 2002
First Posted
July 15, 2002
Study Start
January 1, 2000
Study Completion
December 1, 2003
Last Updated
August 19, 2021
Record last verified: 2004-01