Phase I Trial of Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission
- Any histologically documented stage III or IV epithelial carcinoma arising in the
ovary, fallopian tube or peritoneum.
- History of cytoreductive surgery and chemotherapy with at least one platinum-based
chemotherapy regimen as part of primary treatment.
- Patients must be in a first complete clinical remission. Complete clinical remission
is defined as serum 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 ≤ 1.0cm are often
present in the pelvis and will not be considered definite evidence of disease.
Eligibility is determined by anatomical imaging only (ie. MRI or CT). Positive PET
image (if performed) will not exclude a patient if other criteria are met and
anatomical imaging is negative.
- Adequate organ function defined by
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1,000/mm³, grade 1. Platelets greater than or equal to 100,000/mm³.
- Renal function: Serum creatinine less than or equal to 1.5 x institutional upper
limit normal (ULN), CTCAE v4.0 grade 1.
- Hepatic function: Bilirubin, SGOT, and alkaline phosphatase less than or equal to 2.5
- Negative stool hemoccult (or negative endoscopic evaluation if positive). External
hemorrhoids are a common source of a positive hemoccult and should not exclude
- TSH not elevated above normal range
- KPS > or = to 80%.
- Patients have signed the informed consent document and signed the authorization
permitting release of personal health information.
- Age > 18 years
- Patients must have recovered from clinically significant side effects from prior
- Pregnant or nursing women
- 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
contraindicated this protocol therapy are excluded. Non-melanoma skin cancers are an
exception and will not exclude any patient.
- Patients with a history of a seafood allergy.
- Patients who have previously received a vaccine with any of the antigens in the
- Patients with a history of immunodeficiency or autoimmune disease (excluding treated
- Patients with active CNS tumor.