A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.
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.
Ovarian, Fallopian or Primary Peritoneal Cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.|
- safety & maximally tolerated dose [ Time Frame: Maybe 2 years ] [ Designated as safety issue: Yes ]
- Effectiveness of Alemtuzumab to eliminate VLCs. [ Time Frame: Maybe 2 years ] [ Designated as safety issue: No ]
- Assess molecular markers associated with reduction in VLCs. [ Time Frame: Maybe 2 years ] [ Designated as safety issue: No ]
- Anti-tumor activity measured by decline or stabilization of CA125(a protein that is a tumor marker)or radiological(ie. CT, MRI, X-Ray)improvement or improvement in progression free survival. [ Time Frame: Maybe 2 years ] [ Designated as safety issue: No ]
- Alemtuzumab effect on patients' response rates to chemotherapy given after the discontinuation of chemotherapy. [ Time Frame: Maybe 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks