A Phase 1 Study of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) (NSC 729968) in Patients With Ovarian, Primary Peritoneal and Fallopian Tube Carcinoma

Inclusion Criteria:

- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer

- Recurrent disease after platinum-based chemotherapy

- Must have experienced disease persistence during primary platinum-based therapy
or recurrence within 12 months after completion of platinum-based chemotherapy
("platinum-refractory" or "platinum-resistant" disease)

- A patient receiving a second course of platinum-based chemotherapy for
platinum-sensitive disease who then develops persistence or recurrence
within 12 months is considered eligible for this trial

- Must have measurable disease by RECIST criteria (phase II) (phase II closed as of
1/7/2011)

- Must have received ≥ 1 prior platinum-based cytotoxic chemotherapy regimen (for
primary disease) containing carboplatin, cisplatin, or other organoplatinum compound

- Initial treatment may have included any of the following:

- High-dose therapy

- Consolidation therapy

- Intraperitoneal (IP) therapy

- Extended therapy administered after surgical or nonsurgical assessment

- One additional non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines,
or small-molecule inhibitors) for recurrent or persistent disease allowed

- Patients may have received hormonal therapy for management of disease (e.g., SERMs,
aromatase inhibitors, progestins, and GnRH agonists)

- No loculated ascites for which IP distribution of virus is not expected to be
feasible

- No known brain metastases

- GOG performance status (PS) 0-2 (Karnofsky PS 60-100%)

- Life expectancy > 12 weeks

- Leukocytes ≥ 3,000/mcL

- Absolute neutrophil count ≥ 1,500/mcL

- Hemoglobin ≥ 10 g/dL

- Platelets ≥ 100,000/mcL

- Total bilirubin normal

- AST/ALT ≤ 2.5 times upper limit of normal

- Creatinine normal

- Ejection fraction > 50% by echocardiogram or MUGA

- Cardiac enzymes normal

- Not pregnant or nursing

- Fertile patients must use adequate contraception (hormonal or barrier method of birth
control or abstinence) prior to study entry and for the duration of study
participation

- Must be able to avoid direct contact with pregnant or nursing women, infants, or
immunocompromised individuals while on study and for ≥ 3 weeks following the last
dose of study agent administration

- Cardiac conduction abnormalities (e.g., bundle branch block, heart block) are allowed
if their cardiac status has been stable for 6 months before study entry

- At least 4 weeks since most recent cytotoxic chemotherapy (6 weeks for nitrosoureas
or mitomycin C)

- Recovered from adverse events due to agents administered more than 4 weeks earlier

- No prior radiotherapy to the abdomen or pelvis

- No other concurrent investigational agents

- No investigational or commercial agents or therapies other than those described below
may be administered with the intent to treat the patient's malignancy

Exclusion Criteria:

- Patients in whom insertion of an IP catheter is not feasible due to surgical
contraindications or abdominal and pelvic adhesions

- Known HIV infection or hepatitis B or C

- Clinically significant cardiac disease (New York Heart Association class III or IV
cardiac disease) including any of the following:

- Pre-existing arrhythmia

- Uncontrolled angina pectoris

- Myocardial infarction 1 year prior to study entry

- Compromised left ventricular ejection fraction ≥ grade 2 by MUGA or
echocardiogram

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements

- Chronic oral steroids at an equivalent dose of prednisone 5 mg daily

- Inhaled steroids allowed

- Patients on immunosuppressive therapy

- Concurrent routine prophylactic use of growth factor (filgrastim [G-CSF] or
sargramostim [GM-CSF])