Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Other: Laboratory Biomarker Analysis
  • Biological: Polyvalent Antigen-KLH Conjugate Vaccine
  • Biological: Saponin-based Immunoadjuvant OBI-821

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting