Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response

A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

The purpose of this study is to use an immunologic approach following the treatment for recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.

Patients with epithelial ovarian, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.

Inclusion Criteria:

• Patients with epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, stages I-IV. These patients must have received initial surgery and chemotherapy with at least one platinum based chemotherapy regimen.
• Patients must have relapsed and now have completed chemotherapy for recurrent disease within the last 6 weeks.
• Eligible patients may have asymptomatic residual measurable disease on CT scan, and/or may have an elevated CA-125, or may be in complete clinical remission.
• Patients must have adequate hematologic, renal and hepatic functions.

Exclusion Criteria:

• Patients with any other active malignancy concomitantly
• Patients within 3 weeks of prior cytotoxic or investigational chemotherapy
• Patients within 4 weeks of prior radiotherapy
• Patients within 6 weeks of prior immunotherapy
• Patients who have received any prior anti-cancer vaccine