NCT00693342

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

First QC Date

June 6, 2008

Last Update Submit

February 20, 2020

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage IA primary peritoneal cavity cancerstage IB primary peritoneal cavity cancerstage IC primary peritoneal cavity cancerstage IIA primary peritoneal cavity cancerstage IIB primary peritoneal cavity cancerstage IIC primary peritoneal cavity cancerstage IIIA primary peritoneal cavity cancerstage IIIB primary peritoneal cavity cancerstage IIIC primary peritoneal cavity cancerstage IV primary peritoneal cavity cancerstage IA fallopian tube cancerstage IB fallopian tube cancerstage IC fallopian tube cancerstage IIA fallopian tube cancerstage IIB fallopian tube cancerstage IIC fallopian tube cancerstage IIIA fallopian tube cancerstage IIIB fallopian tube cancerstage IIIC fallopian tube cancerstage IV fallopian tube cancerstage IA ovarian epithelial cancerstage IB ovarian epithelial cancerstage IC ovarian epithelial cancerstage IIA ovarian epithelial cancerstage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (3)

  • Incidence of toxicities

  • Overall survival

  • Correlation of outcome with antigen-specific immune titers in a limited sampling of patients

Study Arms (2)

Arm I

EXPERIMENTAL

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-821Biological: polyvalent antigen-KLH conjugate vaccine

Arm II

EXPERIMENTAL

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

Interventions

immunological adjuvant OPT-821BIOLOGICAL

Given subcutaneously

Arm IArm II
polyvalent antigen-KLH conjugate vaccineBIOLOGICAL

Given subcutaneously

Arm I

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Paul Sabbatini, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

  • Jonathan S. Berek, MD

    Stanford Comprehensive Cancer Center - Palo Alto

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Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 9, 2008

Last Updated

February 24, 2020

Record last verified: 2020-02