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
0
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