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Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab | Drug | will be given Alemtuzumab therapy three times in your first week on the study and then once a week for six additional weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety & maximally tolerated dose | Maybe 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Alemtuzumab to eliminate VLCs. | Maybe 2 years | |
| Assess molecular markers associated with reduction in VLCs. | Maybe 2 years | |
| 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. |
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Inclusion Criteria:
Patients must have a diagnosis of histologically confirmed ovarian, fallopian or primary peritoneal cancer that has progressed or recurred in the abdomen or pelvis after salvage chemotherapy as documented by either:
There is no limit on prior courses of chemotherapy.
Patients must have unidimensional measurable disease or elevated CA125
Age greater than 18 years.
ECOG performance status less tha 2 (Karnofsky 60%).
Life expectancy of greater than 12 weeks.
Patients must have adequate organ and marrow function
Ability 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.
Timing 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.
Women of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Maybe 2 years |
| Alemtuzumab effect on patients' response rates to chemotherapy given after the discontinuation of chemotherapy. | Maybe 2 years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |