Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00041639

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Drug: hMN14 (labetuzumab)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2000

Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hoag Cancer Center	Newport Beach	California	United States	92658
2	Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Bay Pines VA Medical Center	Saint Petersburg	Florida	United States	33744
4	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213
5	Virginia Mason Medical Center	Seattle	Washington	United States	98101-2799
6	Medizinische Fakultaet der Charité Berlin	Berlin		Germany
7	Universitaetsklinikum Leipzig	Leipzig		Germany
8	Semmelweis University	Budapest		Hungary
9	Medical University of Szeged	Szeged		Hungary
10	Academic Medical Center	Amsterdam		Netherlands