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Sponsors and Collaborators: |
Fresenius Biotech GmbH Fresenius Biotech North America |
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Information provided by: | Fresenius Biotech GmbH |
ClinicalTrials.gov Identifier: | NCT00326885 |
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.
Condition | Intervention | Phase |
---|---|---|
Ovarian Neoplasms Ascites |
Drug: catumaxomab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites |
Estimated Enrollment: | 35 |
Study Start Date: | June 2006 |
A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 7 months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the lifetime of the patient.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aaron Enke | 1-866-491-8137 | clinicaltrials@fresenius-biotech.com |
United States, Arizona | |
University of Arizona Cancer Center | Recruiting |
Tucson, Arizona, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, California | |
Stanford University Hospital and Clinics | Recruiting |
Stanford, California, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
University of California | Recruiting |
San Diego, California, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Florida | |
Florida Hospital Cancer Center | Recruiting |
Orlando, Florida, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Indiana | |
Northern Indiana Cancer Research Consortium | Recruiting |
South Bend, Indiana, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Kentucky | |
University of Louisville Cancer Center | Recruiting |
Louisville, Kentucky, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Maryland | |
Johns Hopkins Medical Institute | Not yet recruiting |
Baltimore, Maryland, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, New Hampshire | |
Dartmouth-Hitchock Medical Center | Recruiting |
Lebanon, New Hampshire, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, North Carolina | |
Wake-Forest University | Recruiting |
Winston-Salem, North Carolina, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Oklahoma | |
University of Oklahoma Health Science Center | Recruiting |
Oklahoma City, Oklahoma, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Pennsylvania | |
Magee Women's Hospital, University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com | |
United States, Utah | |
Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States | |
Contact 866-491-8137 clinicaltrials@fresenius-biotech.com |
Study Chair: | Jonathan Berek, MD MMSc | Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology |
Study ID Numbers: | IP-REM-AC-02-US |
Study First Received: | May 15, 2006 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00326885 |
Health Authority: | United States: Food and Drug Administration |
Ascites Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Malignant Ascites Ovarian Cancer Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma |
Peritoneal Cancer Peritoneal Carcinoma Recurrent Ascites Recurrent Malignant Ascites Recurrent Symptomatic Malignant Ascites Symptomatic Malignant Ascites Symptomatic Ascites Malignant ascites Neoplasms, Glandular and Epithelial Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Fallopian Tube Neoplasms Recurrence |
Carcinoma Genital Diseases, Female Antibodies Ascites Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Pathologic Processes Adnexal Diseases |