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

Stage IV Ovarian Cancer Clinical Trial

Official title:

A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933 ) + OPT-821 Versus OPT-821 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who Are in Second or Third Complete Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857545
• Other study ID #: GOG-0255
• Secondary ID: NCI-2009-01176CD
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2009
• Last updated: September 12, 2017
• Start date: July 2010

Study information

• Verified date: December 2016
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms
• 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

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Biological:
• Polyvalent Antigen-KLH Conjugate Vaccine
Given SC
• Saponin-based Immunoadjuvant OBI-821
Given SC

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio
United States	Southwest Gynecologic Oncology Associates Inc	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Northside Hospital	Atlanta	Georgia
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Gynecologic Oncology of West Michigan PLLC	Grand Rapids	Michigan
United States	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina
United States	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina
United States	Saint Francis Hospital	Greenville	South Carolina
United States	Saint Vincent Oncology Center	Indianapolis	Indiana
United States	Kettering Medical Center	Kettering	Ohio
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	Beebe Medical Center	Lewes	Delaware
United States	Lake University Ireland Cancer Center	Mentor	Ohio
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	Stanford Cancer Institute	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery	Phillipsburg	New Jersey
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Center of Hope at Renown Medical Center	Reno	Nevada
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Carilion Clinic Gynecological Oncology	Roanoke	Virginia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	UCSF Medical Center-Mount Zion	San Francisco	California
United States	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina
United States	University of Toledo	Toledo	Ohio
United States	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois
United States	Southeast Clinical Oncology Research (SCOR) Consortium NCORP	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.	Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.
Secondary	Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period	Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.	During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.
Secondary	Overall Survival	Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.	From study entry to death or last contact, up to 5 years of follow-up.