Know Cancer

forgot password

A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of 90YHumanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of 90YHumanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer

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.

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

- 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
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

- Known metastatic disease to the central nervous system.

- Presence of bulky disease (defined as any single mass >10 cm in its greatest

- Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety MTD

Outcome Time Frame:

over the first 12 weeks, then over 2 years

Safety Issue:


Principal Investigator

William Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

October 2007

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • cancer of the pancreas
  • pancreas cancer
  • Pancreatic Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Nebraska Medical Center Omaha, Nebraska  68198
Goshen Cancer Center Goshen, Indiana  46526
University of Medicine and Dentistry Newark, New Jersey  07101