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

Completed · Phase 1

Conditions studied: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

In brief

This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Viral therapy may be able to kill tumor cells without damaging normal cells.

Key facts

Study ID

NCT00602277

Run by

National Cancer Institute (NCI)

People needed

70

Starts

2008-04-01

Expected to finish

2016-08-01

Last updated by the study team

2016-08-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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])

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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