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
- 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.
- To compare the magnitude of the immune responses in these patients at approximately 14
weeks after the initial treatment.
- To determine the frequency and severity of adverse events, as assessed by NCI CTCAE
v3.0, in patients treated with these regimens.
- To characterize the specific humoral immune response, as measured by HAMA and
anti-idiotype antibodies, in these patients.
- 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.
- To characterize the duration of each patient's first progression-free interval after
primary chemotherapy and second progression-free interval after another regimen of
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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Serum human anti-murine antibodies (HAMA) as assessed by enzyme-linked immunosorbent assay (ELISA) at approximately 14 weeks after initial treatment
Robert P. Edwards, MD
University of Pittsburgh
United States: Federal Government