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

NCT01248273 Phase 1 COMPLETED

The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	COMPLETED
Enrolment	26
Start date	2010-11
Completion	2017-03

Conditions

• Fallopian Tubes
• Ovarian Cancer
• Peritoneal Cancer

Interventions

• Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21

Primary outcomes

• To determine immunologic response — 6 months
  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.
• To determine the toxicities following immunization with this unimolecular polyvalent vaccine. — 2 years
  Toxicity will be graded in accordance with the Common Toxicity Criteria Version 4.0 developed by the National Cancer Institute (NCI).
• To determine the maximum tolerated dose over three dose levels. — 2 years
  Six patients will be accrued to one of three pentavalent vaccine doses (25 mcg, 50 mcg and 100 mcg), and an expansion cohort of six patients will be enrolled at the highest dose level achieved.

Countries

United States