NCT01248273

Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fallopian Tubes
• Ovarian Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21	The injection will be administered subcutaneously during weeks 1, 2, 3, 7 and 19, totaling five injections over the course of the study. Three dose levels are planned: 25 mcg, 50 mcg and 100 mcg. We plan to vaccinate six patients at each dose level unless 2 dose limiting toxicities are observed, and an expansion cohort of 6 patients will be enrolled at the highest dose level achieved.

Timeline

• Start date: 2010-11-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2010-11-25
• Last updated: 2017-03-14

Locations

1 site across 1 country: United States