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Completed

NCT Number: NCT00103545

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

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.

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Key information

Conditions

Ovarian Cancer Abdominal Neoplasms Adnexal Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

0 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinic for Gynecology and Gyn. Oncology, Humboldt University, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACA 125

Biological

Primary outcomes

  1. Safety, feasibility and tolerability

  2. The primary endpoint is drop-out due to toxicity as the overall measure of feasibility

Secondary outcomes

  1. Duration and strength of the immune response induced by ACA 125 vaccination

Sponsors and collaborators

Lead sponsor

AGO Study Group

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Feb 11, 2005
Registry last updated
Oct 2, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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