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

NCT00364364 | Terminated Early Phase 1

• 4 other identifiers: J0473CA09848805-02-07-05C-062B-03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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.

Interventions

Radiolabeled humanized PAM4 IgG DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Johns Hopkins Institution, Dept of Radiology and Radiological Science

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Richard Wahl, MD

  Johns Hopkins Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 18, 2019

Record last verified: 2008-12

Locations

US (1)