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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Epithelial Ovarian Cancer, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Demonstrating Clinical Response

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Tyler Curiel, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Food and Drug Administration

Study ID:

HSC20070042H

NCT ID:

NCT00880360

Start Date:

February 2007

Completion Date:

April 2010

Related Keywords:

  • Epithelial Ovarian Cancer
  • Extraovarian Peritoneal Cancer
  • Fallopian Tube Carcinoma
  • Epithelial Ovarian Cancer
  • FIGO (International Federation of Gynecology and Obstetrics )Stage III or Stage IV
  • Extraovarian Peritoneal Cancer
  • Fallopian Tube Carcinoma Failing
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

CTRC at UTHSCSASan Antonio, Texas  78229