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

Phase 1
18 Years
Not Enrolling
Ovarian, Fallopian or Primary Peritoneal Cancer.

Thank you

Trial Information

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

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety & maximally tolerated dose

Outcome Time Frame:

Maybe 2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:

UMCC 2007.120



Start Date:

March 2008

Completion Date:

October 2010

Related Keywords:

  • Ovarian, Fallopian or Primary Peritoneal Cancer.
  • Peritoneal Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752