NCT00004032

Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer

Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer

Detailed description

OBJECTIVES: 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.

Conditions

• Recurrent Ovarian Epithelial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ALVAC-hB7.1	Given IP
BIOLOGICAL	recombinant interferon gamma	Given IP
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 1997-10-01
• Primary completion: 2004-04-01
• First posted: 2003-08-25
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States