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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00693342
• Other study ID #: CDR0000597674
• Secondary ID: GOG-OVM0703
• Status: Withdrawn
• Phase: Phase 3

Study information

• Verified date: February 2020
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• immunological adjuvant OPT-821
Given subcutaneously
• polyvalent antigen-KLH conjugate vaccine
Given subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival
Secondary	Incidence of toxicities
Secondary	Overall survival
Secondary	Correlation of outcome with antigen-specific immune titers in a limited sampling of patients