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

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Extraovarian Peritoneal Cancer; Epithelial Ovarian Cancer; Fallopian Tube Carcinoma

Treatments: Drug: Ontak

Study type: Interventional

Funder types: Other

Identifiers

NCT00880360

OCR 07-04 (Other Identifier)

HSC20070042H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Ontak

Experimental group

Description:

Administration of Ontak IV for treatment of epithelial ovarian cancer

Treatment:

Drug: Ontak