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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

William Wegener, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IM-T-hMN14-03

NCT ID:

NCT00041639

Start Date:

January 2000

Completion Date:

December 2003

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Pancreatic Carcinoma
  • Pancreatic Neoplasms
  • Pancreas Cancer
  • Pancreatic Tumor
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Virginia Mason Medical CenterSeattle, Washington  98111
Washington Hospital CenterWashington, District of Columbia  20010
Hoag Cancer CenterNewport Beach, California  92658
Bay Pines VA Medical CenterSt. Petersburg, Florida  33744