IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer
Condition: FIGO Stage III and IV Ovarian Cancer; FIGO Stage III and IV Fallopian Tube Cancer; FIGO Stage III Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: ALT-803 Subcutaneous; ALT-803 Intraperitoneal
Intervention description: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off); Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex
      (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy
      for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of FIGO stage III or grade IV epithelial ovarian, fallopian tube or primary
             peritoneal carcinoma, has received at least 3 cycles of first line IV/IP cisplatin and
             paclitaxel chemotherapy and has stable disease or better - refer to Appendix II for
             FIGO staging system (Note: to be eligible for this study, the patient must receive a
             minimum of 3 cycles of IP therapy; however, patients may continue on IV only 1st line
             therapy for additional cycles as long as inclusion criteria 4.1.2 is met)

          -  Able to begin study therapy within 3 months of final dose of first line chemotherapy

          -  Functioning intraperitoneal catheter

          -  ≥ 18 years of age

          -  GOG performance status ≤ 2 (Appendix II)

          -  Adequate organ function within 14 days of enrollment defined as:

               -  Hematology: hemoglobin ≥ 8 g/dl, absolute neutrophil count (ANC) ≥ 1500/ul,
                  platelets ≥ 50 x 109/L

               -  Creatinine: ≤ 2.0 mg/dL

               -  Hepatic: SGOT and SGPT ≤ 3 x upper limit of institutional normal (ULN)

          -  Ability to be off prednisone and other immunosuppressive drugs for at least 3 days
             prior to and while receiving ALT-803

          -  Voluntary written consent prior to the performance of any research related procedures

        Exclusion Criteria

          -  Received any investigational agent within the 14 days before the start of ALT-803

          -  Class II or greater New York Heart Association Functional Classification criteria
             (Appendix II) or serious cardiac arrhythmias likely to increase the risk of cardiac
             complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular
             ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)

          -  Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval
             greater than 500 milliseconds)

          -  Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active
             hepatitis C/B - chronic asymptomatic viral hepatitis is allowed

          -  Active autoimmune disease requiring systemic immunosuppressive therapy

          -  History of severe asthma and currently on chronic systemic medications (mild asthma
             requiring inhaled steroids only is eligible)

          -  Uncontrolled hypertension: defined as ≥2 readings over 160 mmHg systolic or 110 mmHg
             diastolic within month prior to enrollment despite optimal anti-hypertensive
             medication. Patients with high readings which improve to ≤160/110 after adjustment of
             medications will be eligible.

          -  History of pulmonary disease or abnormal pulmonary function studies

          -  History of narcolepsy or any neurological condition which may impair consciousness