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

NCT ID: NCT00880360

Last Updated: 2018-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ontak

Administration of Ontak IV for treatment of epithelial ovarian cancer

Group Type EXPERIMENTAL

Ontak

Intervention Type DRUG

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

Interventions

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Ontak

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

Intervention Type DRUG

Other Intervention Names

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Denileukin Diftitox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyler Curiel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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CTRC at UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OCR 07-04

Identifier Type: OTHER

Identifier Source: secondary_id

HSC20070042H

Identifier Type: -

Identifier Source: org_study_id

NCT00238186

Identifier Type: -

Identifier Source: nct_alias

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