Oregovomab 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
RATIONALE: 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.
PURPOSE: 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Serum human anti-murine antibodies (HAMA) as assessed by enzyme-linked immunosorbent assay (ELISA) at approximately 14 weeks after initial treatment [ Designated as safety issue: No ]
- Frequency and severity of adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Serum HAMA and anti-idiotype antibodies as assessed by ELISA over the course of treatment [ Designated as safety issue: No ]
- Frequency and magnitude of patients who have a delayed-type hypersensitivity (DTH) response to oregovomab, tetanus, mumps, and Candida as assessed by DTH skin testing [ Designated as safety issue: No ]
- Duration of time from first response to first recurrence [ Designated as safety issue: No ]
- Duration of time from second response to second recurrence [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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 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.
|Study Chair:||Robert P. Edwards, MD||University of Pittsburgh|
|Investigator:||Maurie Markman, MD||M.D. Anderson Cancer Center|
|Investigator:||Joseph A. Lucci, MD||University of Miami Sylvester Comprehensive Cancer Center|