Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 to 65 NCI UNMC-04194 NCI-B92-0019, B92-0019

Objectives

I.  Correlate the administered dose of yttrium-90-labeled monoclonal antibody 
CC49 (90Y-MOAB CC49) with predicted absorbed tumor dose in patients with 
unresectable or metastatic adenocarcinoma of the gastrointestinal tract, using 
indium-111-labeled monoclonal antibody CC49 for imaging.

II.  Determine whether absorbed doses of 4,000 cGy of 90Y-MOAB CC49 can be 
reached in metastatic sites.

III.  Determine the maximum tolerated dose of 90Y-MOAB CC49.

Entry Criteria

Disease Characteristics:

Histologic diagnosis of gastrointestinal adenocarcinoma not amenable to
potentially curable treatment as follows:
  Gastric:
     Unresectable or metastatic
     Failed at least 1 course of a fluorouracil-containing regimen

  Colorectal:
     Metastatic
     Failed at least 1 course of fluorouracil-containing regimen

  Pancreatic:
     Unresectable or metastatic
     No prior therapy required

  Esophageal:
     Unresectable
     Standard radiotherapy with or without chemotherapy required for
        symptomatic disease prior to entry

Greater than 30% reactivity of primary or metastatic tumor cells with MOAB
CC49
  Serum TAG at least 15 U/ml if MOAB reactivity test not feasible

No CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:
  No prior murine antibody immunotherapy
     HAMA negativity required following prior exposure to murine antibody
     reagent for imaging studies

Chemotherapy:
  At least 4 weeks since chemotherapy
  See Disease Characteristics for site-specific requirements

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy
  See Disease Characteristics for esophageal primaries

Surgery:
  Full recovery from prior surgery (usually 4 weeks) required

Patient Characteristics:

Age:
  18 to 65

Performance status:
  ECOG 0 or 1

Life expectancy:
  At least 3 months

Hematopoietic:
  WBC greater than 3,500
  Platelets greater than 150,000

Hepatic:
  Bilirubin less than 2.0 mg/dl
  SGOT no greater than 5 x ULN
  Alkaline phosphatase no greater than 5 x ULN
  PT less than 13 seconds
  PTT less than 37 seconds

Renal:
  Creatinine less than 2.0 mg/dl

Other:
  No serious active medical condition requiring active medical management,
  including:
     Infection
     Diabetes
     Heart disease
     Hypertension
  No mental incompetence
  No pregnant women
  Effective contraception required of fertile patients

Expected Enrollment

18-36 patients will be entered over 9-12 months.

Outline

Radioimmunotherapy.  Yttrium-labeled Murine Monoclonal Antibody CC49, 90Y-MOAB 
CC49, NSC-647944.

Trial Contact Information

Trial Lead Organizations

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Margaret Tempero, MD, Protocol chair		Ph: 415-885-3846; 800-888-8664 Email: mtempero@medicine.ucsf.edu