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Sponsored by: |
Immunomedics, Inc. |
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Information provided by: | Immunomedics, Inc. |
ClinicalTrials.gov Identifier: | NCT00603863 |
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 I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase Ib Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic Cancer. |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Arms | Assigned Interventions |
---|---|
multiple dose levels: Experimental
1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.
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Biological: IMMU-107 (hPAM4)
90Y-hPAM4 once weekly for 3 weeks gemcitabine once weekly for 4 weeks
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After confirming eligibility and undergoing baseline assessments, all patients receive 111In-hPAM4 administered at least one week prior to scheduled therapy, with scintigraphic images and blood samples obtained at intervals over 7 days for analysis of tumor targeting, biodistribution, dosimetry, and pharmacokinetics. The Investigator must confirm there is acceptable biodistribution for therapeutic treatment and the radiation dose estimates for the planned cohort 90Y doses must not exceed defined organ radiation dosimetry limits (i.e., 3,000 cGy for liver, 2,000 cGy for the lungs and kidneys, 300 cGy for red bone marrow). Otherwise the patient is not eligible for radioimmunotherapy with 90Y-hPAM4. 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 onceweekly 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 retreatment or for a maximum period of 12 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant or lactating.
Contact: Heather Horne | 973-727-7589 | hhorne@immunomedics.com |
United States, California | |
Hoag Cancer Center | Not yet recruiting |
Newport Beach, California, United States, 92658 | |
United States, Delaware | |
Christiana Care Health Services | Recruiting |
Newark, Delaware, United States, 19718 | |
United States, Florida | |
Sylvester Comprehensive Cancer Center | Recruiting |
Miami, Florida, United States, 33136 | |
Moffit Cancer Center | Not yet recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Susan Garl 973-727-7195 sgarl@immunomedics.com | |
United States, Indiana | |
Goshen Cancer Center | Recruiting |
Goshen, Indiana, United States, 46526 | |
Contact: Rebecca Eickhoff, RN 574-535-2974 reickhoff@goshenhealth.com | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
New York Presbyterian Hospital/Weill Cornell Medical Center | Not yet recruiting |
New York, New York, United States, 10021 | |
Mt. Sinai Medical Center | Not yet recruiting |
New York, New York, United States, 10029 | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Susan Garl 973-727-7195 sgarl@immunomedics.com | |
Contact: Heather Horne | |
United States, Ohio | |
Ohio State University Medical Center | Not yet recruiting |
Columbus, Ohio, United States, 43210 | |
United States, Wisconsin | |
Aspirus REgional Cancer Center | Not yet recruiting |
Wausau, Wisconsin, United States, 54401 |
Study Chair: | William Wegener, MD, PHD | Immunomedics, Inc. |
Responsible Party: | Immunomedics, INc. ( William Wegener, MD, PhD ) |
Study ID Numbers: | IM-T-hPAM4-02 |
Study First Received: | January 8, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00603863 |
Health Authority: | United States: Food and Drug Administration |
pancreatic cancer hPAM4 MUC1 antibody cancer of the pancreas |
Antibodies Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Pancrelipase Immunoglobulins Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |