Clinical trial NCT01416038 (phase 1, status: completed)
Conditions: ovarian cancer, fallopian tube cancer, peritoneal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C57.00, C57.01, C57.02, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: low dose cyclophosphamide (oral)
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        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