Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

This is an interventional treatment trial for Ovarian Cancer focused on measuring vaccine, immunotherapy, ovarian, fallopian tube, peritoneal, cancer, tumor, Phase 1, Phase I, combination therapy Read More

Main Inclusion Criteria:

• Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
• Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy.
• Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac
• At least 30 days since localized surgery, radiotherapy or chemotherapy
• Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac

Main Exclusion Criteria:

• Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded
• Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
• Subjects who have received more than one course of chemotherapy for recurrent disease
• Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)
• History of autoimmune disease
• Subjects with recent history of thyroiditis
• Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis
• Subjects with brain metastases
• Concurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
• Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
• Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product
• Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A
• Allergies to any component of the vaccine
• Pregnant or nursing mothers
• Subjects with a medical or psychological impediment to probable compliance with the protocol