OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission
Condition: Stage IA Fallopian Tube Cancer; Stage IA Ovarian Cancer; Stage IB Fallopian Tube Cancer; Stage IB Ovarian Cancer; Stage IC Fallopian Tube Cancer; Stage IC Ovarian Cancer; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Cancer; Stage IIB Fallopian Tube Cancer; Stage IIB Ovarian Cancer; Stage IIC Fallopian Tube Cancer; Stage IIC Ovarian Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Laboratory Biomarker Analysis; Polyvalent Antigen-KLH Conjugate Vaccine; Saponin-based Immunoadjuvant OBI-821
Intervention description: Correlative studies; Given SC; Given SC
Intervention MeSH terms: Adjuvants, Immunologic
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 171.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work
      compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian
      tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still
      be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in
      different ways and stop tumor cells from growing. Vaccines may help the body build an
      effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more
      effective with or without vaccine therapy in treating patients with ovarian epithelial
      cancer, fallopian tube cancer, or peritoneal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically documented epithelial carcinoma arising in the ovary,
             fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must
             have had cytoreductive surgery and chemotherapy with at least one platinum-based
             chemotherapy regimen as part of primary treatment

          -  Patients who recurred on or after initial therapy, and are now in a second or third
             complete clinical remission and who are within four months of their last treatment are
             eligible; complete clinical remission is defined as serum cancer antigen (CA)-125
             within institutional normal limits, negative physical examination, and no definite
             evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes
             and/or soft tissue abnormalities =< 1.0 cm are often present in the pelvis and will
             not be considered definite evidence of disease; eligibility is determined by
             anatomical imaging only (ie. magnetic resonance imaging [MRI] or CT); a positive
             positron emission tomography (PET) image (if performed) will not exclude a patient if
             other criteria are met and anatomical imaging is negative

          -  Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3, equivalent to
             Common Toxicity Criteria for Adverse Events (CTCAE version [v]4.0) grade 1

          -  Platelets greater than or equal to 100,000/mm^3

          -  Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN),
             CTCAE v4.0 grade 1

          -  Bilirubin less than or equal to 2.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminse
             (SGPT) less than or equal to 2.5 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or
             2

          -  Patients who have signed the informed consent document and signed the authorization
             permitting release of personal health information

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             study entry and must be practicing an effective form of birth control; nursing mothers
             are excluded

        Exclusion Criteria:

          -  With the exception of non-melanoma skin cancer, patients with other invasive
             malignancies who had (or have) any evidence of the other cancer present within the
             last 5 years or whose previous cancer treatment contraindicates this protocol therapy
             are excluded

          -  Patients whose circumstances at the time of entry onto the protocol would not permit
             completion of study or required follow up

          -  Patients who have an allergy to shellfish