Ovarian Cancer Clinical 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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

171

Study ID:

NCT00857545

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 45 Locations for this study

See Locations Near You

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
Saint 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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

171

Study ID:

NCT00857545

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

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