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



Status:Completed
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/14/2017
Start Date:July 2010

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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

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.

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.

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
We found this trial at
45
sites
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Albuquerque, NM
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Akron, OH
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Albuquerque, New Mexico 87106
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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Anderson, SC
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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Charlotte, North Carolina 28204
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303 East Superior Street
Chicago, Illinois 60611
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Elkton, Maryland 21921
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Grand Rapids, Michigan 49546
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
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Indianapolis, Indiana 46260
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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9485 Mentor Ave
Mentor, Ohio 44060
(440) 205-5755
Lake University Ireland Cancer Center Lake Health is a private, not-for-profit leader in community health...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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1660 Springhill Avenue
Mobile, Alabama 36604
(251) 665-8000
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19111
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Providence, Rhode Island 02905
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Roanoke, Virginia 24016
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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San Francisco, California 94115
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Spartanburg, South Carolina 29307
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
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