Ovarian Cancer Clinical Trial
Official title:
A Randomized Phase III Trial in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer With a Polyvalent Vaccine-KLH Conjugate + OPT-821 Versus OPT-821
RATIONALE: Vaccines made from tumor antigens may help the body build an effective immune
response to kill tumor cells. Biological therapies, such as OPT-821, may stimulate the immune
system in different ways and stop tumor cells from growing. Giving vaccine therapy together
with OPT-821 may kill more tumor cells. It is not yet known whether giving vaccine therapy
together with OPT-821 is more effective than OPT-821 alone in treating ovarian epithelial
cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase III trial is studying vaccine therapy and OPT-821 to see how
well they work compared with OPT-821 alone in treating patients with ovarian epithelial
cancer, fallopian tube cancer, or primary peritoneal cancer in complete remission.
OBJECTIVES:
Primary
- To compare the progression-free survival of patients with ovarian epithelial, fallopian
tube, or primary peritoneal cancer in second or third complete clinical remission
treated with a polyvalent antigen-KLH conjugate vaccine (GM2-KLH, Globo-H-KLH,
Tn-MUC1-32mer-KLH, TF-KLH, and sTn-KLH) in combination with OPT-821 vs OPT-821 alone.
Secondary
- To compare the incidence of toxicities in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
- To characterize the immune response (by ELISA) in a limited sampling of patients, in
order to determine if the outcome correlates with antigen-specific immune titers.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive polyvalent antigen-KLH conjugate vaccine in combination with
OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
- Arm II: Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75,
and 87.
Patients undergo blood sample collection periodically for correlative studies. Samples are
analyzed for antibody expression to antigens (i.e., Tn-MUC1-32mer, GM2, Globo-H, TF, sTN, and
Tn) by ELISA. IgM and IgG titers are also measured.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
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