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
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
5 other identifiers
interventional
171
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedResults Posted
Study results publicly available
September 6, 2017
CompletedSeptember 13, 2017
December 1, 2016
5.2 years
March 5, 2009
December 20, 2016
September 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period
During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.
Overall Survival
From study entry to death or last contact, up to 5 years of follow-up.
Study Arms (2)
Arm I (vaccine therapy and adjuvant)
EXPERIMENTALPatients 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 (adjuvant)
EXPERIMENTALPatients receive immunological adjuvant OPT-821 SC as in arm I.
Interventions
Correlative studies
Given SC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (46)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Stanford Cancer Institute
Palo Alto, California, 94304, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Saint Vincent Oncology Center
Indianapolis, Indiana, 46260, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, 49546, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Center of Hope at Renown Medical Center
Reno, Nevada, 89502, United States
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery
Phillipsburg, New Jersey, 08865, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Toledo
Toledo, Ohio, 43614, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 31653510DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Gedeon for Wei Deng PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Sabbatini
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
July 1, 2010
Primary Completion
September 1, 2015
Last Updated
September 13, 2017
Results First Posted
September 6, 2017
Record last verified: 2016-12