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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364364
Recruitment Status : Terminated (Loss of funding)
First Posted : August 15, 2006
Last Update Posted : December 17, 2008
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Radiolabeled humanized PAM4 IgG Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
Study Start Date : May 2007
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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.
  2. An examination of how the pharmacokinetics and tumor targeting are affected by the amount of hPAM4 IgG administered.
  3. Targeting with 111In-hPAM4 will be compared to other radiological (e.g., CT) and nuclear (FDG-PET; optional)findings.
  4. For patients who undergo surgery after the 111In-hPAM4 study, targeting will be correlated against surgical findings.

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

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:-

  • 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.

Exclusion Criteria:

A.Subjects with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study. These include, but are not restricted to

  1. Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
  2. Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.

B. Subjects who have signs of intestinal obstruction.

C. Subjects who are pregnant are excluded. D. Subjects who have a measurable antibody response to hPAM4 in their pre-study sample or who are proven allergic upon testing with the agent.

E. Patients who are known to have HIV.

F. Patients who have a known history of Hepatitis B or C or any other serious liver abnormality will be excluded from enrollment.

G. Prisoners or other institutionalized persons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364364

United States, Maryland
Johns Hopkins Institution, Dept of Radiology and Radiological Science
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Principal Investigator: Richard Wahl, MD Johns Hopkins Institution Identifier: NCT00364364     History of Changes
Other Study ID Numbers: J0473
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases