Status:
TERMINATED
A Phase I Study of Alemtuzumab in Patients With Relapsed Ovarian/Primary Peritoneal Cancer.
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 sup...
Eligibility Criteria
Inclusion
- 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:
- Radiologic studies or
- 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.
- 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
- Patients with known immunosuppressive diseases are excluded from this trial due to the known immunosuppressive nature of Alemtuzumab therapy.
- Patients may not be receiving any other agents (investigational or otherwise) with therapeutic intent.
- 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.
- Patients with a history of allergic reactions to Alemtuzumab or other humanized immunotherapeutics.
- 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.
- Patients with history of active CMV disease as Alemtuzumab therapy has been associated with CMV reactivation.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00637390
Start Date
March 1 2008
End Date
October 1 2010
Last Update
December 2 2016
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109