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A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer. | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT00637390•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+4 more criteria

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.

Locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

December 2, 2016

Enrollment

ACTUAL participants

Conditions

Ovarian CancerFallopian Tube CancerPeritoneal Cancer

Interventions

Alemtuzumab

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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