A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.



Status:Terminated
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/3/2016
Start Date:March 2008
End Date:October 2010

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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.


Inclusion Criteria:

1. 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:

1. Radiologic studies or

2. Rising CA125 levels on two independent measurements. If the patient's CA125 has
fallen into a normal range, CA125 relapse will be defined as double the nadir
CA125. However, if the patients CA125 nadir had fallen to less than 10, then the
measurements documenting recurrence or progression must be greater than 20.

2. There is no limit on prior courses of chemotherapy.

3. Patients must have unidimensional measurable disease or elevated CA125

4. Age greater than 18 years.

5. ECOG performance status less tha 2 (Karnofsky 60%).

6. Life expectancy of greater than 12 weeks.

7. Patients must have adequate organ and marrow function

8. 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.

9. 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:

1. Patients with known immunosuppressive diseases are excluded from this trial due to
the known immunosuppressive nature of Alemtuzumab therapy.

2. Patients may not be receiving any other agents (investigational or otherwise) with
therapeutic intent.

3. Patients with prior malignancy, except for adequately treated basal cell (or squamous
cell) skin cancer, in situ cervical cancer or other cancer for which the patient has
been disease free for 2 years.

4. Patients with a history of allergic reactions to Alemtuzumab or other humanized
immunotherapeutics.

5. Patients with unresolved bacterial, fungal, or viral infections requiring active
treatment. Patients may be registered two weeks after the conclusion of antibiotic or
anti-viral therapy.

6. Patients with history of active CMV disease as Alemtuzumab therapy has been
associated with CMV reactivation.
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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mi
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Ann Arbor, MI
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