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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

Phase 1
19 Years
Open (Enrolling)
Fallopian Tubes, Ovarian Cancer, Peritoneal Cancer

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Trial Information

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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
current trial.

- Patients with a history of immunodeficiency or autoimmune disease (excluding treated

- Patients with active CNS tumor.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine immunologic response

Outcome Description:

immunization with the unimolecular pentavalent carbohydrate-based vaccine bearing Globo-H, GM2, sTn, TF and Tn on a single polypeptide backbone, conjugated to KLH, mixed with the immunological adjuvant QS-21, induces an IgG and IgM antibody response against these individual antigens and tumor cells expressing these antigens.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Fallopian Tubes
  • Ovarian Cancer
  • Peritoneal Cancer
  • MUC-1 KLH
  • QS-21
  • TF(C)-KLH
  • TN(C)-KLH
  • Immunization
  • Vaccine
  • 09-184
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021