Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Randomized Pilot Trial of Consolidation With an Adjuvant Ovarian Cancer Vaccine Oregovomab (Ovarex ®) With/Without Single-Dose Cyclophosphamide After a Complete Clinical Response to Second-Line Taxane/Platinum-Based Therapy to Determine Immune Response and Time to Progression in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
This randomized clinical trial is studying the side effects of oregovomab and to see how well it works with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that responded to second-line chemotherapy. Monoclonal antibodies, such as oregovomab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether oregovomab is more effective when given together with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
I. To characterize the nonspecific humoral immune response, as measured by human anti-murine
antibodies (HAMA), in patients with stage III or IV ovarian epithelial, fallopian tube, or
primary peritoneal adenocarcinoma treated with consolidation therapy comprising adjuvant
oregovomab with vs without cyclophosphamide after achieving a complete clinical response to
second-line taxane/platinum-based therapy.
II. To compare the magnitude of the immune responses in these patients at approximately 14
weeks after the initial treatment.
III. To determine the frequency and severity of adverse events, as assessed by NCI CTCAE
v3.0, in patients treated with these regimens.
SECONDARY OBJECTIVES:
I. To characterize the specific humoral immune response, as measured by HAMA and
anti-idiotype antibodies, in these patients.
II. To assess the treatment emergent cellular immune response, by measuring the delayed-type
hypersensitivity response to the anergy panel and to oregovomab as compared to baseline, in
these patients.
III. To characterize the duration of each patient's first progression-free interval after
primary chemotherapy and second progression-free interval after another regimen of
chemotherapy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo delayed-type hypersensitivity (DTH) skin testing with oregovomab and
a standard anergy panel (i.e., mumps, Candida, and tetanus toxoid) on day 0 (at baseline) and
at week 14. The skin test response is measured 48 hours later. Patients receive
cyclophosphamide IV on day 6 and oregovomab IV over 20 minutes on day 9 or 10. Patients then
receive oregovomab alone at weeks 6 and 10 and then every 12 weeks for up to 2 years (10
doses) in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo DTH skin testing and receive oregovomab as in arm I.
Blood samples are obtained from patients at baseline and at weeks 14 and 38 for immunologic
correlative studies. Samples are examined to determine CA-125 levels and human anti-murine
antibody (HAMA) and anti-idiotype antibody levels by enzyme-linked immunosorbent assay
(ELISA).
After completion of study therapy, patients are followed every 3 months for 2 years and then
every 6 months for 3 years.
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