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

This study has been withdrawn prior to enrollment.

(Never opened to accrual, a GOG working number, not developed into a clinical trial.)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Gynecologic Oncology Group

ClinicalTrials.gov Identifier:

NCT00693342

First received: June 6, 2008

Last updated: April 8, 2013

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 6, 2008

Last Updated Date

April 8, 2013

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free survival [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00693342 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of toxicities [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: No ]
Correlation of outcome with antigen-specific immune titers in a limited sampling of patients [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Biological: immunological adjuvant OPT-821

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00693342

Other Study ID Numbers ^ICMJE

CDR0000597674, GOG-OVM0703

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Paul Sabbatini, MD	Memorial Sloan-Kettering Cancer Center
Investigator:	Jonathan S. Berek, MD	Stanford Comprehensive Cancer Center - Palo Alto

Information Provided By

Gynecologic Oncology Group

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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