Clinical Trials

A Phase I Trial of a New Vaccine (Globo-H-GM2-sTn-TF-Tn) for Patients with Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission

Protocol
09-184
Full Title
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
Purpose

The purpose of this study is to evaluate the safety and preliminary effectiveness of a new vaccine designed to train the immune system to recognize and fight ovarian, fallopian tube, or peritoneal cancer cells. The vaccine is being assessed in patients with these cancers who have achieved a first remission and have a high risk of cancer recurrence. Investigators will assess various doses of the vaccine.

The vaccine in this study contains antigens or “fingerprints” that are found on many cancer cells, especially those from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen). The antigens in this vaccine are called Globo-H, GM2, sTn, TF, and Tn. They have been assessed in patients individually; this is the first time all of the antigens have been put together on a single molecule and evaluated in patients.

The antigens are given with a material called QS-21, which may help the immune system to make more cancer-fighting cells. The group of antigens is attached to a material called keyhole limpet hemocyanin (KLH), which has been used for many years to boost the immune system in laboratory animals and in people.

Investigator
Paul Sabbatini, MD
Paul Sabbatini - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be in first remission from stage III or IV ovarian, fallopian tube, or peritoneal cancer following surgery and platinum-based chemotherapy.
  • Patients must also have one of these characteristics: had not reached a normal CA125 level by the third cycle of chemotherapy (but have a normal CA125 level now); had suboptimal debulking surgery (as determined by the doctor); or have clear cell or mucinous features on the pathology specimen.
  • Patients must have recovered from the side effects of prior treatment.
  • Because KLH is derived from shellfish, patients with a seafood allergy may not participate.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Sabbatini at 646-888-4218.

Disease(s)
Ovarian Cancer
Locations
ClinicalTrials.gov
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