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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

Primary Purpose

Stage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IB Fallopian Tube Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Polyvalent Antigen-KLH Conjugate Vaccine
Saponin-based Immunoadjuvant OBI-821
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IA Fallopian Tube Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama Mitchell Cancer Institute
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • Stanford Cancer Institute
  • UCSF Medical Center-Mount Zion
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Northside Hospital
  • Northwestern University
  • Northwestern Medicine Cancer Center Warrenville
  • Saint Vincent Oncology Center
  • Greater Baltimore Medical Center
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Union Hospital of Cecil County
  • Gynecologic Oncology of West Michigan PLLC
  • Washington University School of Medicine
  • Women's Cancer Center of Nevada
  • Center of Hope at Renown Medical Center
  • The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
  • University of New Mexico Cancer Center
  • Southwest Gynecologic Oncology Associates Inc
  • University of New Mexico Cancer Center
  • Winthrop University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • Carolinas Medical Center/Levine Cancer Institute
  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
  • Summa Akron City Hospital/Cooper Cancer Center
  • University of Cincinnati
  • Case Western Reserve University
  • Miami Valley Hospital
  • Kettering Medical Center
  • Lake University Ireland Cancer Center
  • University of Toledo
  • University of Oklahoma Health Sciences Center
  • Abington Memorial Hospital
  • Fox Chase Cancer Center
  • Women and Infants Hospital
  • AnMed Health Cancer Center
  • Saint Francis Hospital
  • Greenville Health System Cancer Institute-Faris
  • Greenville Health System Cancer Institute-Eastside
  • Greenville Health System Cancer Institute-Spartanburg
  • Huntsman Cancer Institute/University of Utah
  • Virginia Commonwealth University/Massey Cancer Center
  • Carilion Clinic Gynecological Oncology
  • Froedtert and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (vaccine therapy and adjuvant)

Arm II (adjuvant)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 5, 2009
Last Updated
September 12, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00857545
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (vaccine therapy and adjuvant)
Arm Type
Experimental
Arm Description
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 Title
Arm II (adjuvant)
Arm Type
Experimental
Arm Description
Patients receive immunological adjuvant OPT-821 SC as in arm I.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Biological
Intervention Name(s)
Polyvalent Antigen-KLH Conjugate Vaccine
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
Saponin-based Immunoadjuvant OBI-821
Other Intervention Name(s)
OBI-821, OPT-821
Intervention Description
Given SC
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
Description
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Time Frame
During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.
Title
Overall Survival
Description
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.
Time Frame
From study entry to death or last contact, up to 5 years of follow-up.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sabbatini
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSF Medical Center-Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Saint Vincent Oncology Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Gynecologic Oncology of West Michigan PLLC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Center of Hope at Renown Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
City
Phillipsburg
State/Province
New Jersey
ZIP/Postal Code
08865
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Southwest Gynecologic Oncology Associates Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Summa Akron City Hospital/Cooper Cancer Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Lake University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Greenville Health System Cancer Institute-Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Health System Cancer Institute-Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Greenville Health System Cancer Institute-Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Clinic Gynecological Oncology
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31653510
Citation
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.
Results Reference
derived

Learn more about this trial

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

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