Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, cancer of the pancreas, pancreas cancer
Brief summary
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
Detailed description
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.
Interventions
BIOLOGICAL90Y-hPAM4
Single dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety MTD | over the first 12 weeks, then over 2 years |
Secondary
| Measure | Time frame |
|---|---|
| targeting, biodistribution, organ dosimetry | first 2 weeks |
| pharmacokinetics (PK), antigenicity, | first 12 weeks |
| efficacy | over first 12 weeks, then over 2 years |
Countries
United States
Outcome results
None listed