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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
Not Recruiting
Trial ID: NCT00857545
Purpose
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.
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
Stanford Investigator(s)
Jonathan S. Berek, MD, MMSc
Laurie Kraus Lacob Professor
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
Intervention(s):
biological: polyvalent antigen-KLH conjugate vaccine
other: laboratory biomarker analysis
biological: Saponin-based Immunoadjuvant OBI-821
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061