Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00004032|
Recruitment Status : Completed
First Posted : August 25, 2003
Last Update Posted : January 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Ovarian Epithelial Cancer||Biological: ALVAC-hB7.1 Biological: recombinant interferon gamma Other: laboratory biomarker analysis||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 1997|
|Actual Primary Completion Date :||April 2004|
U.S. FDA Resources
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
- Autologous tumor cell cytotoxicity lymphocyte (CTL) [ Time Frame: Up to 7 years ]
- Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR [ Time Frame: Up to 7 years ]
- Toxicity as assessed by NCI Common Terminology Criteria (CTC) [ Time Frame: 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004032
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ralph Freedman||M.D. Anderson Cancer Center|