OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission

NCT ID: NCT00857545

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

Brief Summary

This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin [KLH], Globo-H-KLH, Tn-mucin 1 [MUC1]-32mer-KLH, and Thompson Friedreich antigen [TF]-KLH plus OPT-821) decreases the hazard of progression or death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.

SECONDARY OBJECTIVES:

I. To compare the treatment arms with respect to the incidence of toxicities. II. To determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.

TERTIARY OBJECTIVES:

I. To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in participants, in order to determine if the outcome correlates with antigen-specific immune titers.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive immunological adjuvant OPT-821 SC as in Arm I.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

Stage IA Fallopian Tube Cancer; Stage IA Ovarian Cancer; Stage IB Fallopian Tube Cancer; Stage IB Ovarian Cancer; Stage IC Fallopian Tube Cancer; Stage IC Ovarian Cancer; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Cancer; Stage IIB Fallopian Tube Cancer; Stage IIB Ovarian Cancer; Stage IIC Fallopian Tube Cancer; Stage IIC Ovarian Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm I (vaccine therapy and adjuvant)

Patients receive polyvalent antigen-KLH conjugate vaccine and immunological adjuvant OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71, and 83 in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Polyvalent Antigen-KLH Conjugate Vaccine

Intervention Type: BIOLOGICAL

Given SC

Saponin-based Immunoadjuvant OBI-821

Intervention Type: BIOLOGICAL

Given SC

Arm II (adjuvant)

Patients receive immunological adjuvant OPT-821 SC as in arm I.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Saponin-based Immunoadjuvant OBI-821

Intervention Type: BIOLOGICAL

Given SC

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Polyvalent Antigen-KLH Conjugate Vaccine

Given SC

Intervention Type: BIOLOGICAL

Saponin-based Immunoadjuvant OBI-821

Given SC

Intervention Type: BIOLOGICAL

Other Intervention Names

OBI-821; OPT-821

Eligibility Criteria

Inclusion Criteria

• Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment
• Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging [MRI] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative
• Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version [v]4.0) grade 1
• Platelets greater than or equal to 100,000/mm^3
• Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
• Bilirubin less than or equal to 2.5 x ULN
• Serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminse (SGPT) less than or equal to 2.5 x ULN
• Alkaline phosphatase less than or equal to 2.5 x ULN
• Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
• Patients who have signed the informed consent document and signed the authorization permitting release of personal health information
• Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of birth control; nursing mothers are excluded

Exclusion Criteria

• With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
• Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
• Patients who have an allergy to shellfish

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Sabbatini

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Saint Vincent Oncology Center

Indianapolis, Indiana, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Union Hospital of Cecil County

Elkton, Maryland, United States

Gynecologic Oncology of West Michigan PLLC

Grand Rapids, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Center of Hope at Renown Medical Center

Reno, Nevada, United States

The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery

Phillipsburg, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Southwest Gynecologic Oncology Associates Inc

Albuquerque, New Mexico, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Winthrop University Hospital

Mineola, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, United States

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Case Western Reserve University

Cleveland, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Lake University Ireland Cancer Center

Mentor, Ohio, United States

University of Toledo

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

AnMed Health Cancer Center

Anderson, South Carolina, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, United States

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

O'Cearbhaill RE, Deng W, Chen LM, Lucci JA 3rd, Behbakht K, Spirtos NM, Muller CY, Benigno BB, Powell MA, Berry E, Tewari KS, Hanjani P, Lankes HA, Aghajanian C, Sabbatini PJ. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study. Gynecol Oncol. 2019 Dec;155(3):393-399. doi: 10.1016/j.ygyno.2019.09.015. Epub 2019 Oct 22.

Reference Type: DERIVED

PMID: 31653510 (View on PubMed)

Other Identifiers

NCI-2009-01176

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000636384

Identifier Type: -

Identifier Source: secondary_id

GOG-0255

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0255

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0255

Identifier Type: -

Identifier Source: org_study_id