Safety Study To Determine The Appropriate Dose Of Antibody Against Tumor Cells To Best Target Patients With Pancreatic Cancer.

Study Overview

Safety Study to Determine the Appropriate Dose of Antibody Against Tumor Cells to Best Target Patients With Pancreatic Cancer.

This no treatment research study is being done to find a safe and an appropriate dose of antibody (protein) against tumor cells to best target the cancer in people with pancreatic cancer. To do this, this no-treatment research study will compare two doses of an antibody called hPAM4 IgG when combined with a radioactive element, Indium-111.

This is an open-label, single-center, non-randomized, single-arm, pilot imaging study to determine the pharmacokinetics, biodistribution, and tumor targeting of an indium-111 (111In)-labeled, humanized anti-MUC1 antibody, designated hPAM4 IgG1 in patients with known pancreatic cancer. The primary objective of this trial is to examine how changing the protein dose will affect these parameters with the intent to determine if a single protein dose can be selected to optimize tumor targeting. It is expected that these data will aid in the selection of an appropriate protein dose to be used in a Phase I therapy trial with yttrium-90 (90Y)-labeled hPAM4 IgG. The secondary objective is to monitor safety. Pharmacokinetics, biodistribution, tumor targeting, and dosimetry (modeling for 90Y) will be assessed against clinical parameters, such as pre-study PAM4-reactive MUC-1 antigen in the serum, tumor size, location, histopathology, immunohistology, and if possible, antigen content by extraction of tumor sample.

Pancreatic Cancer

DRUG: Radiolabeled humanized PAM4 IgG

J0473
CA098488
05-02-07-05 (OTHER Identifier) (OTHER: JHM IRB)
C-062B-03 (REGISTRY Identifier) (REGISTRY: NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-08-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-16
First Submitted that Met QC Criteria 2006-08-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-18
First Posted (ACTUAL) 2006-08-15	Results First Posted N/A	Last Verified 2008-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Examine the pharmacokinetics and tumor targeting of 111In-DOTA-hPAM4 anti-MUC-1 IgG given intravenously to patients with known or a suspicion of primary or recurrent pancreatic cancer.
An examination of how the pharmacokinetics and tumor targeting are affected by the amount of hPAM4 IgG administered.
Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.
For patients who undergo surgery after the 111In-hPAM4 study, targeting will be correlated against surgical findings.

Secondary Outcome Measures	Measure Description	Time Frame
Correlate tumor targeting, when feasible, with the following:Immunohistology using the hPAM4 antibody
Histology,Serum antigen content
Determine normal organ and, whenever possible, tumor dosimetry for 90Y-hPAM4 IgG based on the distribution and tumor targeting of 111In-hPAM4-IgG.
Monitor the development of antibody formation to the hPAM4, when feasible.
Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
21 Years

Accepts Healthy Volunteers:

All patients must either have a histologic or cytological diagnosis of pancreatic cancer or a high clinical suspicion of pancreatic cancer.
Patients must be 21 years of age.
Patients must have measurable disease by CT scan.
Patients must be at least 4 weeks beyond any major surgery.
Patients must be at least 4 weeks beyond any chemotherapy or radiation therapy and must have recovered from treatment-induced toxicity.
Patients must have a performance status of 70% or greater on the Karnofsky Scale and a minimal life expectancy of 3 months.
Patients must not have severe anorexia, nausea or vomiting, and no signs of intestinal obstruction.
Patients must have a serum creatinine that is < 1.5 x the Institutional Upper Limit of Normal (IULN).
AST/ALT < 2 times the IULN; serum bilirubin < 3 x IULN.
WBC 3000/mm3, a granulocyte count 1500/mm3, and a platelet count 100,000/mm3.
Patients must sign an informed consent, and be mentally responsible. There will be no discrimination based on race, creed, or ethnic background.
Patients must be able to return to an approved study site for the scheduled follow-up procedures.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Richard Wahl, MD, Johns Hopkins Institution

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record