A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 10, 2008 |
| Last Updated Date | June 18, 2012 |
| Start Date ICMJE | March 2008 |
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
safety & maximally tolerated dose [ Time Frame: Maybe 2 years ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00637390 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer. |
| Official Title ICMJE | A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer. |
| Brief Summary | Ovarian cancer cannot grow without recruiting new blood vessels. Studies in humans 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 given subcutaneously (under the skin)can be safely given to patients with ovarian, fallopian, or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab, by eliminating VLCs, can restrict tumor growth or increase response rates to chemotherapy given after the discontinuation of chemotherapy. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 1 |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Ovarian, Fallopian or Primary Peritoneal Cancer. |
| Intervention ICMJE | 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 |
| Study Arm (s) | Experimental: one
Intervention: Drug: Alemtuzumab |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | 3 |
| Completion Date | October 2010 |
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
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. Women of all races and ethnic groups are eligible for this trial. Exclusion Criteria:
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| Gender | Female |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00637390 |
| Other Study ID Numbers ICMJE | UMCC 2007.120 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Ronald Buckanovich, University of Michigan Cancer Center |
| Study Sponsor ICMJE | Ronald Buckanovich |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Michigan Cancer Center |
| Verification Date | June 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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