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A Phase I Study of Alemtuzumab Delivered Intraperitoneally in Patients With Relapsed Ovarian Cancer
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, October 2008
First Received: March 10, 2008   Last Updated: October 4, 2008   History of Changes
Sponsored by: University of Michigan Cancer Center
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00637390
  Purpose

Ovarian cancer cannot grow without recruiting new blood vessels. We 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 can be safely given in the abdominal cavity of ovarian cancer patients to kill VLCs and determine if Alemtuzumab, by eliminating VLCs, can restrict ovarian tumor growth or enhance subsequent responses to chemotherapy


Condition Intervention Phase
Recurrent Ovarian Cancer Not Responsive to Standard Chemo
Drug: Alemtuzumab
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Campath Alemtuzumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Study of Alemtuzumab Delivered Intraperitoneally in Patients With Relapsed Ovarian Cancer.

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • safety & maximally tolerated dose [ Time Frame: maybe 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
one: Experimental Drug: Alemtuzumab
will be given Alemtuzumab therapy three times in their first week on the study and then once a week for six additional weeks
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a diagnosis of histologically confirmed ovarian cancer that has progressed or recurred in the abdomen or pelvis after salvage chemotherapy as documented by either radiologic studies or rising CA125 levels.
  2. Patients must have large volume ascites- confirmed by radiologic studies.
  3. There is no limit on prior courses of chemotherapy.
  4. Patients must have unidimensional measurable disease or elevated CA125 and large volume ascites.

5Age >18 years.

6ECOG performance status <2 (Karnofsky >60%, see Appendix A).

7Life expectancy of greater than 12 weeks.

8Patients must have adequate organ and marrow function

9Ability 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.

10Timing 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.

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 metastases outside the abdominal cavity are excluded from this clinical trial.
  5. Patients with a history of allergic reactions to Alemtuzumab or other humanized immunotherapeutics.
  6. 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.
  7. Patients with history of active CMV disease as Alemtuzumab therapy has been associated with CMV reactivation.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637390

Contacts
Contact: Cancer Answer Line 1 800 865 1125 canceranswerline@umich.edu
Contact: Ronald Buckanovich, MD 734 764 2395 ronaldbu@umich.edu

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ronald Buckanovich, M.D.     734-764-2395     ronaldbu@umich.edu    
Contact: Cancer Answer Line     800 865 1125     canceranswerline@umich.edu    
Principal Investigator: Ronald Buckanovich, M.D.            
Sponsors and Collaborators
University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan ( Dr. Ronald Buckanovich )
Study ID Numbers: UMCC 2007.120
Study First Received: March 10, 2008
Last Updated: October 4, 2008
ClinicalTrials.gov Identifier: NCT00637390     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Alemtuzumab
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Gonadal Disorders
Antineoplastic Agents
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Alemtuzumab
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009