Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy

This is an interventional treatment trial for Recurrent Fallopian Tube Carcinoma Read More

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])