Clinical trial NCT00637390 (phase 1, status: terminated)
Conditions: ovarian cancer, fallopian tube cancer, peritoneal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C57.00, C57.01, C57.02, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: alemtuzumab
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    genzyme will no longer supply the study drug for this trial as it does not believe the study
    will not fully enroll within an appropriate time frame.
  
Eligibility criteria:

        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.