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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597129
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
Information provided by:
Immunomedics, Inc.

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: 90Y-hPAM4 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Multi Dose levels
different doses of 90YhPAM4 will be given only once.
Biological: 90Y-hPAM4
Single dose of 90Y-hPAM4 will be given and all patients will be followed for 12 weeks.
Other Names:
  • 111-IN-hPAM4
  • MUC-1 antibody

Primary Outcome Measures :
  1. safety MTD [ Time Frame: over the first 12 weeks, then over 2 years ]

Secondary Outcome Measures :
  1. targeting, biodistribution, organ dosimetry [ Time Frame: first 2 weeks ]
  2. pharmacokinetics (PK), antigenicity, [ Time Frame: first 12 weeks ]
  3. efficacy [ Time Frame: over first 12 weeks, then over 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00597129

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United States, Indiana
Goshen Cancer Center
Goshen, Indiana, United States, 46526
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
University of Medicine and Dentistry
Newark, New Jersey, United States, 07101
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Immunomedics, Inc.
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Study Chair: William Wegener, MD, PhD Immunomedics, Inc.

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Responsible Party: William Wegener, MD, PHD, Immunomedics, Inc. Identifier: NCT00597129    
Obsolete Identifiers: NCT00303680
Other Study ID Numbers: IM-T-hPAM4-01
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008
Keywords provided by Immunomedics, Inc.:
pancreatic cancer
cancer of the pancreas
pancreas cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases