Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
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
Recurrent Ovarian Epithelial Cancer
Biological: recombinant interferon gamma
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study|
- Autologous tumor cell cytotoxicity lymphocyte (CTL) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI Common Terminology Criteria (CTC) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 1997|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ALVAC-hB7.1, recombinant interferon gamma)
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.
Given IPBiological: recombinant interferon gamma
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004032
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ralph Freedman||M.D. Anderson Cancer Center|