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Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
This study has been completed.
Study NCT00041639   Information provided by Immunomedics, Inc.
First Received: July 11, 2002   Last Updated: June 23, 2005   History of Changes

July 11, 2002
June 23, 2005
January 2000
 
 
 
Complete list of historical versions of study NCT00041639 on ClinicalTrials.gov Archive Site
 
 
 
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

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

 
Phase I, Phase II
Interventional
Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Pancreatic Neoplasms
Drug: hMN14 (labetuzumab)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
75
December 2003
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hungary,   Netherlands
 
NCT00041639
 
IM-T-hMN14-03
Immunomedics, Inc.
 
Study Chair: William Wegener, MD Immunomedics, Inc.
Immunomedics, Inc.
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP