Expired Study
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Houston, Texas 77030


Purpose:

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


Study summary:

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.


Criteria:

Inclusion Criteria: - Diagnosis of ovarian epithelial carcinoma - Previously treated with an adequate course of platinum based chemotherapy - Evidence of intraabdominal disease - No significant adhesions - Performance status - Zubrod 0-2 - Lymphocyte count at least 500/mm^3 - Bilirubin no greater than 1.5 mg/dL - SGOT less than 2.5 times upper limit of normal - Creatinine no greater than 1.5 mg/dL - No major disorder of the cardiovascular system - No major disorder of the pulmonary system - Not pregnant or nursing - Fertile patients must use effective contraception - Successful placement of peritoneal catheter - No overt autoimmune disease - No concurrent chronic steroid therapy - No prior radiotherapy - Prior surgery allowed - Recovered from prior therapy


NCT ID:

NCT00004032


Primary Contact:

Principal Investigator
Ralph Freedman
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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