Safety and Efficacy Study of 90Y-hPAM4 at Different Doses

Completed · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT00597129

Run by

Gilead Sciences

People needed

21

Starts

2004-08-01

Expected to finish

2007-10-01

Last updated by the study team

2021-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Goshen Cancer Center — Goshen, Indiana, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• University of Medicine and Dentistry — Newark, New Jersey, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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