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
Verified date | December 2016 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 171 |
Est. completion date | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
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. |
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