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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880360
First Posted: April 13, 2009
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
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.

Condition Intervention Phase
Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma Drug: Ontak Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Toxicity [ Time Frame: 3 years ]
    Determine any toxicity associated with Ontak treatment in these patients.


Enrollment: 19
Study Start Date: February 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ontak Drug: Ontak
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Other Name: Denileukin Diftitox

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880360


Locations
United States, Texas
CTRC at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Tyler Curiel, MD, PhD The University of Texas Health Science Center at San Antonio
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00880360     History of Changes
Obsolete Identifiers: NCT00238186
Other Study ID Numbers: HSC20070042H
OCR 07-04 ( Other Identifier: UTHSCSA )
First Submitted: April 10, 2009
First Posted: April 13, 2009
Results First Submitted: August 13, 2012
Results First Posted: October 19, 2012
Last Update Posted: December 5, 2017
Last Verified: January 2013

Keywords provided by The University of Texas Health Science Center at San Antonio:
Epithelial Ovarian Cancer
FIGO (International Federation of Gynecology and Obstetrics )Stage III or Stage IV
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma Failing

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Denileukin diftitox
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs