Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission

Brief Title

Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission

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

Brief Summary

      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.

Detailed Description

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Progression-free survival

Secondary Outcome

 Incidence of toxicities

Condition

Fallopian Tube Cancer

Intervention

immunological adjuvant OPT-821

Study Arms / Comparison Groups

 Arm I

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
             cancer

               -  Any stage or grade at diagnosis allowed

          -  Has undergone initial cytoreductive surgery or received at least one platinum-based
             chemotherapy regimen

               -  Recurred on initial therapy, but is now in second or third complete clinical
                  remission as defined by the following:

                    -  Serum CA-125 normal

                    -  Negative physical examination

                    -  No definitive evidence of disease by CT scan of the abdomen and pelvis
                       (lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered
                       definitive evidence of disease)

                         -  A positive PET scan is allowed provided other criteria are met and MRI
                            or CT scan are negative

               -  Completed last course of chemotherapy within the past 4 months

        PATIENT CHARACTERISTICS:

          -  GOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 2.0 times ULN

          -  SGOT ≤ 2.0 times ULN

          -  Alkaline phosphatase ≤ 2.0 times ULN

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

Gender

Female

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Paul Sabbatini, MD, ,

Administrative Informations

NCT ID

NCT00693342

Organization ID

CDR0000597674

Secondary IDs

GOG-OVM0703

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Paul Sabbatini, MD, Study Chair, Memorial Sloan Kettering Cancer Center

Verification Date

February 2020