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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00693342

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Biological: immunological adjuvant OPT-821 Biological: polyvalent antigen-KLH conjugate vaccine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Primary Purpose:

Treatment

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

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: immunological adjuvant OPT-821 Given subcutaneously Biological: polyvalent antigen-KLH conjugate vaccine Given subcutaneously
Experimental: Arm II Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.	Biological: immunological adjuvant OPT-821 Given subcutaneously

Arm

Intervention/Treatment

Experimental: 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.

Biological: immunological adjuvant OPT-821

Given subcutaneously

Biological: polyvalent antigen-KLH conjugate vaccine

Given subcutaneously

Experimental: Arm II

Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.

Biological: immunological adjuvant OPT-821

Given subcutaneously

Outcome Measures

Primary Outcome Measures

Progression-free survival []

Secondary Outcome Measures

Incidence of toxicities []
Overall survival []
Correlation of outcome with antigen-specific immune titers in a limited sampling of patients []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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