Back to resultsVaccine 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
Primary Purpose
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
immunological adjuvant OPT-821
polyvalent antigen-KLH conjugate vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage IA primary peritoneal cavity cancer, stage IB primary peritoneal cavity cancer, stage IC primary peritoneal cavity cancer, stage IIA primary peritoneal cavity cancer, stage IIB primary peritoneal cavity cancer, stage IIC primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IA fallopian tube cancer, stage IB fallopian tube cancer, stage IC fallopian tube cancer, stage IIA fallopian tube cancer, stage IIB fallopian tube cancer, stage IIC fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I
Arm II
Arm 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.
Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
Outcomes
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
Full Information
NCT ID
NCT00693342
First Posted
June 6, 2008
Last Updated
February 20, 2020
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00693342
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Never opened to accrual, a GOG working number, not developed into a clinical trial.
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
stage IA primary peritoneal cavity cancer, stage IB primary peritoneal cavity cancer, stage IC primary peritoneal cavity cancer, stage IIA primary peritoneal cavity cancer, stage IIB primary peritoneal cavity cancer, stage IIC primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IA fallopian tube cancer, stage IB fallopian tube cancer, stage IC fallopian tube cancer, stage IIA fallopian tube cancer, stage IIB fallopian tube cancer, stage IIC fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm 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.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
Intervention Type
Biological
Intervention Name(s)
immunological adjuvant OPT-821
Intervention Description
Given subcutaneously
Intervention Type
Biological
Intervention Name(s)
polyvalent antigen-KLH conjugate vaccine
Intervention Description
Given subcutaneously
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Incidence of toxicities
Title
Overall survival
Title
Correlation of outcome with antigen-specific immune titers in a limited sampling of patients
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sabbatini, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathan S. Berek, MD
Organizational Affiliation
Stanford Comprehensive Cancer Center - Palo Alto
12. IPD Sharing Statement
Learn more about this trial
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
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