Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
21 Years
N/A
Both
Pancreatic Cancer
Trial Information
Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose
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.
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.
-
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Outcome Measure:
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.
Principal Investigator
Richard Wahl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins Institution
Authority:
United States: Food and Drug Administration
Study ID:
J0473
NCT ID:
NCT00364364
Start Date:
May 2007
Completion Date:
June 2008
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Johns Hopkins Institution, Dept of Radiology and Radiological Science | Baltimore, Maryland 21287 |
