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Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00603863
First received: January 8, 2008
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: IMMU-107 (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 Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer.

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc. [ Time Frame: over 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2008
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: multiple dose levels
1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.
Biological: IMMU-107 (hPAM4)
90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
Other Names:
  • hPAM4
  • IMMU-107
  • 90Y-hPAM4
  • anti-mucin antibody

Detailed Description:

Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.

  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 pancreatic adenocarcinoma.
  • Stage III (locally advanced, unresectable) or Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections.
  • Treatment naïve (no prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer)
  • Karnofsky performance status > 70 % (Appendix A).
  • Expected survival > 3 months.
  • At least 4 weeks beyond major surgery 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 > 11 g/dL, ANC > 2,000 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 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 or prevent completion of study procedures and follow-up examinations.
  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: NCT00603863

Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, Florida
Herbert Werthem College of Medicine/Jackson North Medical Center
Miami, Florida, United States, 33169
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Moffit Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute/Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Indiana
Goshen Cancer Center
Goshen, Indiana, United States, 46526
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William Wegener, MD, PHD Immunomedics, Inc.
  More Information

Publications:

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT00603863     History of Changes
Other Study ID Numbers: IM-T-hPAM4-02
Study First Received: January 8, 2008
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
pancreatic cancer
hPAM4
MUC1 antibody
cancer of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014