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

This study has been completed.
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00597129
First received: January 8, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Pancreatic Cancer
Biological: 90Y-hPAM4
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • safety MTD [ Time Frame: over the first 12 weeks, then over 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • targeting, biodistribution, organ dosimetry [ Time Frame: first 2 weeks ] [ Designated as safety issue: Yes ]
  • pharmacokinetics (PK), antigenicity, [ Time Frame: first 12 weeks ] [ Designated as safety issue: Yes ]
  • efficacy [ Time Frame: over first 12 weeks, then over 2 years ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • 90Y-hPAM4
  • 111-IN-hPAM4
  • MUC-1 antibody

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597129

Locations
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.
Investigators
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
  More Information

Publications:

Responsible Party: William Wegener, MD, PHD, Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT00597129     History of Changes
Obsolete Identifiers: NCT00303680
Other Study ID Numbers: IM-T-hPAM4-01
Study First Received: January 8, 2008
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
pancreatic cancer
cancer of the pancreas
pancreas cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014