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OpenTrials
Completed

NCT Number: NCT00880360

A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer

This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma 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 Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CTRC at UTHSCSA

San Antonio, Texas, 78229, United States

About this study

This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide informed consent
  • Not on Immune modulating drugs
  • Life expectancy less than 6 months

Exclusion criteria

  • Unable to tolerate phlebotomy
  • Germ cell or stromal cell cancers of the ovaries
  • Active autoimmune disease

Treatment and study plan

ONTAK

Drug

Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Other names: Denileukin Diftitox

Primary outcomes

  1. Number of Participants Demonstrating Clinical Response

    Time frame: 2 years

    Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.

Secondary outcomes

  1. Toxicity

    Time frame: 3 years

    Determine any toxicity associated with Ontak treatment in these patients.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy

Acronym: ONTAK

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2009
Registry last updated
Mar 27, 2018

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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