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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00637390 |
Ovarian cancer cannot grow without recruiting new blood vessels. We have identified a novel cell population, termed vascular leukocytes (VLCs). While VLCs are not cancer cells, they support the growth of ovarian cancer cells by stimulating the growth of new blood vessels which provide the cancer with nutrients. VLCs make a protein termed CD52. An antibody therapeutic, Alemtuzumab (also know as Campath), that kills cells that make the CD52 protein has been successfully used to treat certain lymphomas (a type of blood cell cancer) that make CD52 protein. The purpose of this study is to determine if Alemtuzumab can be safely given in the abdominal cavity of ovarian cancer patients to kill VLCs and determine if Alemtuzumab, by eliminating VLCs, can restrict ovarian tumor growth or enhance subsequent responses to chemotherapy
Condition | Intervention | Phase |
---|---|---|
Recurrent Ovarian Cancer Not Responsive to Standard Chemo |
Drug: Alemtuzumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Alemtuzumab Delivered Intraperitoneally in Patients With Relapsed Ovarian Cancer. |
Estimated Enrollment: | 25 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
one: Experimental |
Drug: Alemtuzumab
will be given Alemtuzumab therapy three times in their first week on the study and then once a week for six additional weeks
Drug: Alemtuzumab
will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
5Age >18 years.
6ECOG performance status <2 (Karnofsky >60%, see Appendix A).
7Life expectancy of greater than 12 weeks.
8Patients must have adequate organ and marrow function
9Ability to understand and the willingness to sign a written informed consent document. All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.
10Timing guideline for pre-study labs and measurements:
All pre-study labs required for determination of eligibility are to be completed within 28 days of treatment Day 1.
X-rays and/or scans used for tumor measurement to determine disease status are to be completed within 28 days of treatment Day 1.
Exclusion Criteria:
Patients with history of active CMV disease as Alemtuzumab therapy has been associated with CMV reactivation.
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Contact: Cancer Answer Line | 1 800 865 1125 | canceranswerline@umich.edu |
Contact: Ronald Buckanovich, MD | 734 764 2395 | ronaldbu@umich.edu |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Ronald Buckanovich, M.D. 734-764-2395 ronaldbu@umich.edu | |
Contact: Cancer Answer Line 800 865 1125 canceranswerline@umich.edu | |
Principal Investigator: Ronald Buckanovich, M.D. |
Responsible Party: | University of Michigan ( Dr. Ronald Buckanovich ) |
Study ID Numbers: | UMCC 2007.120 |
Study First Received: | March 10, 2008 |
Last Updated: | October 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00637390 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Alemtuzumab Genital Neoplasms, Female Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Recurrence Endocrine Gland Neoplasms |
Ovarian Neoplasms Gonadal Disorders Antineoplastic Agents Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Pharmacologic Actions |
Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Alemtuzumab Endocrine Gland Neoplasms |