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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
To determine immunologic response
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.
Time frame: 6 months
To determine the toxicities following immunization with this unimolecular polyvalent vaccine.
Toxicity will be graded in accordance with the Common Toxicity Criteria Version 4.0 developed by the National Cancer Institute (NCI).
Time frame: 2 years
To determine the maximum tolerated dose over three dose levels.
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.
Time frame: 2 years
To record the progression free interval
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.