Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies

Inclusion Criteria

• Patients must have stage IV peritoneal surface dissemination of gastrointestinal cancer or recurrent ovarian, fallopian tube or primary peritoneal cancer with metastatic disease to the peritoneum that cannot be completely resected at time of abdominal exploration. Please note:
• Locoregional extension of peritoneal disease beyond the peritoneal cavity (including but not limited to the pleura and subcutaneous soft tissue) is permitted with PI approval,
• Radiographically measurable disease is preferable, but for patients with previously documented gastrointestinal, fallopian tube, ovarian, or primary peritoneal cancer, for whom relevant tumor markers (including but not limited to CEA, CA 19-9 or CA-125) have been useful markers of disease progression and/or response to treatment, an elevated relevant tumor marker (including but not limited to CEA, CA 19-9 or CA-125) above the institutional upper limit of normal could be substituted for radiographic imaging,
• Asymptomatic primary tumors are permitted.
• Subjects must have had at least one prior round of systemic therapy or have refused or be ineligible for standard systemic therapy for their disease type. No prior systemic therapy is required for low grade mucinous cancers.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2
• Adequate marrow function as evidenced by:
• Absolute neutrophil count (ANC) ≥ 2,000/µL
• Platelets ≥ 100,000/µL
• Hemoglobin (Hgb) ≥ 9 g/dL
• Adequate renal function as evidenced by serum creatinine ≤ 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 x ULN.
• Adequate hepatic function as evidenced by:
• Serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN
• Aspartate aminotransferase (AST) ≤ 3 x ULN
• Alanine aminotransferase (ALT) ≤ 3 x ULN
• Alkaline phosphatase ≤ 3 x ULN
• INR or PT ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy, in which case PT and PTT/aPTT must be within therapeutic range of intended use of anticoagulants (and may need to be held per institutional standards for placement of the Bard peritoneal catheter).
• Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy.
• Patients of reproductive potential (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) at the time of pregnancy test (women of childbearing potential only), during the course of the study and for 90 days after the last dose of study drug, even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of study and for 90 days after the last dose of study drug.
• Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.

Exclusion Criteria

• Prior chemotherapy, radiotherapy, biological cancer therapy, targeted therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
• Patients who received radiotherapy to more than 25% of their bone marrow.
• Currently receiving treatment with another investigational device or drug study, or 10 mg/day of prednisone or equivalent. The exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
• Metastatic disease in a site other than the peritoneal surfaces. Note: Locoregional extension of peritoneal disease may be permitted with PI approval.
• History or evidence of active autoimmune disease that requires systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive dru