search
Back to results

Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
hMN14 (labetuzumab)
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic Cancer, Pancreatic Carcinoma, Pancreatic Neoplasms, Pancreas Cancer, Pancreatic Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hoag Cancer Center
  • Washington Hospital Center
  • Bay Pines VA Medical Center
  • University of Pittsburgh Cancer Institute
  • Virginia Mason Medical Center
  • Medizinische Fakultaet der Charité Berlin
  • Universitaetsklinikum Leipzig
  • Semmelweis University
  • Medical University of Szeged
  • Academic Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2002
Last Updated
August 12, 2021
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00041639
Brief Title
Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
Pancreatic Cancer, Pancreatic Carcinoma, Pancreatic Neoplasms, Pancreas Cancer, Pancreatic Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
hMN14 (labetuzumab)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wegener, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bay Pines VA Medical Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-2799
Country
United States
Facility Name
Medizinische Fakultaet der Charité Berlin
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Facility Name
Medical University of Szeged
City
Szeged
Country
Hungary
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

We'll reach out to this number within 24 hrs