Expired Study
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Philadelphia, Pennsylvania 19111


Purpose:

Safety study to determine highest dose of 90Y-hPAM4 can be safety administered


Study summary:

radiolabeled anti-MUC1 humanized antibody) administered intravenously as a single dose to patients with locally advanced and/or metastatic pancreatic cancer. The primary objective is to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of 90Y-hPAM4 in this population. Secondary objectives include the assessment of tumor targeting, biodistribution, organ dosimetry and pharmacokinetics (PK) of 90Y-hPAM4 as determined by pre-therapy administration of 111In-hPAM4, the assessment of the antigenicity of 90Y-hPAM4, as determined by development of human anti-humanized antibodies (HAHA), and to obtain preliminary information on the efficacy of single dose 90Y-hPAM4 in this patient population.


Criteria:

Inclusion Criteria: - Male or female patients, >18 years of age, who are able to understand and give written informed consent. - Histologically or cytologically confirmed, Stage III or IV pancreatic adenocarcinoma. - Patients with Stage III (locally advanced) disease must have documented progression after failing primary therapy - Patients with Stage IV (metastatic) disease must not have received more than one chemotherapy regimen. - Measurable disease by CT, with at least on lesion >1.5 cm in one dimension. - Karnofsky performance status > 70 % (Appendix A). - Expected survival > three months. - At least 4 weeks beyond chemotherapy, radiotherapy, major surgery, other experimental treatments, and recovered from all acute toxicities. - At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis - Adequate hematology without ongoing transfusional support (hemoglobin > 10 g/dL, ANC > 1,500 per mm3, platelets > 150,000 per mm3) - Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN) - Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v3.0. Exclusion Criteria: - Women who are pregnant or lactating. - Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period. - Known metastatic disease to the central nervous system. - Presence of bulky disease (defined as any single mass >10 cm in its greatest dimension) - Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction. - Prior treatment with nitrosureas, actinomycin-D, radioimmunotherapy or other antibody-based therapies (murine, chimeric, humanized or human) Prior radiation dose >3,000 cGy to the liver, >2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow. - Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5- year disease free interval. - Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive. - 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. - Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids). - Infection requiring intravenous antibiotic use within 1 week. - Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation


NCT ID:

NCT00597129


Primary Contact:

Study Chair
William Wegener, MD, PhD
Immunomedics, Inc.


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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