Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study
I. Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells
infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any
clinical responses in patients with refractory ovarian epithelial cancer.
OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.
Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and
18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of
disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells
are available to continue treatment with tumor cell derived vaccine, interferon gamma may be
given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected
tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose at which no more than 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Autologous tumor cell cytotoxicity lymphocyte (CTL)
Up to 7 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|