Recurrent Ovarian Epithelial Cancer Clinical Trial
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
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
Status | Completed |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | April 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Autologous tumor cell cytotoxicity lymphocyte (CTL) | Up to 7 years | No | |
Primary | Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR | Up to 7 years | No | |
Primary | Toxicity as assessed by NCI Common Terminology Criteria (CTC) | 3 weeks | Yes |
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