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Home > "S" Clinical Trials Conditions > Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer  Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
For Condition: Pancreatic Neoplasms
Status: Completed
Sponsor(s): Immunomedics, Inc. ,
Synopsis: The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of pancreatic cancer.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 75
Location and Contact Information:
Overall Study Official:
WilliamWegener, Study Chair, Immunomedics, Inc.
Academic Medical Center
Amsterdam, ,
Netherlands
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Universitaetsklinikum Leipzig
Leipzig, ,
Germany
Bay Pines VA Medical Center
St. Petersburg, Florida, 33744
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Semmelweis University
Budapest, ,
Hungary
Hoag Cancer Center
Newport Beach, California, 92658
United States
Medizinische Fakultaet der Charité Berlin
Berlin, ,
Germany
Medical University of Szeged
Szeged, ,
Hungary
Virginia Mason Medical Center
Seattle, Washington, 98101-2799
United States
Additional Information:
Study ID Numbers: IM-T-hMN14-03;
Study Start Date: January 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041639
Other Pancreatic Neoplasms Studies:
1. A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
2. A multicenter phase 2 study of CI-1040 in patients with advanced nonsmall-cell lung cancer, breast cancer, colon cancer, or pancreatic cancer
3. Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas
4. A Phase 3 Trial of ALIMTA (LY231514, pemetrexed) plus GEMZAR Versus GEMZAR in Patients with Unresectable or Metastatic Cancer of the Pancreas.
5. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
Related Studies:
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Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
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