Status:
TERMINATED
Safety Study to Determine the Appropriate Dose of Antibody Against Tumor Cells to Best Target Patients With Pancreatic Cancer.
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
21+ years
Phase:
EARLY_PHASE1
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, ...
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, humanize...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
- 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.
- \-
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00364364
Start Date
May 1 2007
End Date
August 1 2008
Last Update
January 18 2019
Active Locations (1)
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1
Johns Hopkins Institution, Dept of Radiology and Radiological Science
Baltimore, Maryland, United States, 21287