Clinical trial NCT00041639: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic Cancer
Pancreatic Carcinoma
Pancreatic Neoplasms
Pancreas Cancer
Pancreatic Tumor
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2002-07-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Cancer Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Saint Petersburg
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Berlin
country: Germany
facility: Medizinische Fakultaet der Charité Berlin
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Budapest
country: Hungary
facility: Semmelweis University
city: Szeged
country: Hungary
facility: Medical University of Szeged
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Gilead Sciences
name: William Wegener, MD
role: STUDY_CHAIR
References: