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

PRIMARY OBJECTIVES:

I. To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin [KLH],
Globo-H-KLH, Tn-mucin 1 [MUC1]-32mer-KLH, and Thompson Friedreich antigen [TF]-KLH plus
OPT-821) decreases the hazard of progression or death compared to a vaccine containing
OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in
second or third complete clinical remission.

SECONDARY OBJECTIVES:

I. To compare the treatment arms with respect to the incidence of toxicities. II. To
determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine
containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal
cancer in second or third complete clinical remission.

TERTIARY OBJECTIVES:

I. To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in
participants, in order to determine if the outcome correlates with antigen-specific immune
titers.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant
OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive immunological adjuvant OPT-821 SC as in Arm I.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.

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