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Sponsored by: |
Immunomedics, Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303680 |
RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA monoclonal antibody HuPAM4, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be effective treatment for pancreatic cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA monoclonal antibody HuPAM4 in treating patients with stage III or stage IV pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: monoclonal antibody HuPAM4 Drug: yttrium Y 90 DOTA monoclonal antibody HuPAM4 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I, Dose-Escalating Study to Investigate the Safety, Tolerability, Pharmacokinetics and Dosimetry of a Single Dose of Y-Humanized PAM4 IgG in Patients With Locally Advanced/Metastatic Pancreatic Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | August 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, dose-escalation study of yttrium Y 90 DOTA monoclonal antibody HuPAM4 (Y90 DOTA MOAB HuPAM4).
Patients receive unconjugated monoclonal antibody HuPAM4 IV over 30-60 minutes followed by indium In 111 DOTA monoclonal antibody HuPAM4 IV over 30-60 minutes. Patients then undergo imaging and blood sampling over 1 week to evaluate tumor targeting, biodistribution, and organ dosimetry. Approximately 1 week later, patients with adequate biodistribution, definitive tumor targeting, and acceptable organ dosimetry receive unconjugated monoclonal antibody HuPAM4 IV over 30-60 minutes followed by Y90 DOTA MOAB HuPAM4 IV over 30-60 minutes.
Cohorts of 3-6 patients receive escalating doses of Y90 DOTA MOAB HuPAM4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients (total of 16) are treated at the MTD.
Patients who do not receive Y90 DOTA MOAB HuPAM4 are followed at weeks 1, 4, 8, and 12 and then monthly for at least 6 months. After completion of study treatment, all other patients are followed periodically for 5 years.
PROJECTED ACCRUAL: Approximately 28-40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic adenocarcinoma
Stage III disease
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Immunologic
No autoimmune disease or autoimmune phenomena
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids, except if medically necessary
Radiotherapy
Surgery
Other
United States, Indiana | |
Center for Cancer Care at Goshen General Hospital | Recruiting |
Goshen, Indiana, United States, 46526 | |
Contact: Clinical Trials Office - Center for Cancer Care at Goshen Gene 574-535-2858 | |
United States, New Jersey | |
UMDNJ University Hospital | Recruiting |
Newark, New Jersey, United States, 07103 | |
Contact: Moumita Chakraborty 973-972-7889 | |
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 |
Study Chair: | William A. Wegener, MD, PhD | Immunomedics, Inc. |
Study ID Numbers: | CDR0000419744, IM-T-HPAM4-01, UMDNJ-0120020277 |
Study First Received: | March 15, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00303680 |
Health Authority: | Unspecified |
adenocarcinoma of the pancreas stage III pancreatic cancer recurrent pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Recurrence Antibodies, Monoclonal Antibodies |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms Immunoglobulins |
Neoplasms Neoplasms by Site Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |