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A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer

A Phase II Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, Extraovarian Peritoneal or Fallopian Tube Carcinoma or Ineligible for First-Line Therapy

NCT01773889•The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial ovarian cancers, enhancing treatment efficacy.

Detailed Description

The aims of this study are to: * Assess the efficacy of adding pegylated IFN-α2b to denileukin diftitox to treat selected advanced-stage epithelial ovarian cancers * Test the immune-modulating effects of adding pegylated IFN-α2b to denileukin diftitox in ovarian cancer patients and relate them to clinical efficacy * Identify any toxicity associated with pegylated IFN-α2b plus denileukin diftitox treatment in these patients * Identify practical means to dose the immunomodulating agents denileukin diftitox and pegylated IFN-α2b based on immunopharmacodynamic metrics

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Able to provide informed consent
•Not on immune-modulating drugs, except those used as denileukin diftitox premedication, unless the principal investigator grants an exception (which exception must be documented in writing)
•Histologically proven epithelial (non-germ cell, non-stromal cell) cancer of the ovaries, fallopian tubes or extraovarian peritoneal carcinoma. Clinical recurrence without documented pathology is acceptable
•FIGO stage III or IV with failed prior first-line therapy, or ineligible for or intolerant of such therapy
•Measurable disease as defined in section 6 within 30 days of study enrollment
•Blood hemoglobin ≥ 8.5 gm/dl within 7 days of study enrollment
•Absolute neutrophil count ≥ 750/mm3 within 7 days of study enrollment
•Platelet count ≥ 40,000/mm3 within 7 days of study enrollment
•SGOT (serum glutamic oxaloacetic transaminase) ≤10 x upper limit of normal within 7 days of study enrollment
•Normal TSH (thyroid-stimulating hormone ) within 30 days of study enrollment
+14 more criteria

Exclusion Criteria

•Unable to tolerate phlebotomy
•Germ cell or stromal cell cancers of the ovaries, or other currently uncured cancer
•Active autoimmune disease including systemic lupus erythematosus, psoriasis, or inflammatory bowel disease that is not medically controlled
•Autoimmune hepatitis, whether medically controlled or not
•Contraindication to any study drug
•Known hypersensitivity to denileukin diftitox, pegylated IFN-α2a or any of their components or excipients
•Current pregnancy or breast feeding
•Inability to document adequate contraception if a female of reproductive potential
•On other immune-modulating drugs, except denileukin diftitox premedications or those approved by the principal investigator
•Chemotherapy within 14 days or radiation therapy within the thirty days prior to initiation of study treatment
+10 more criteria

Locations (1)

CTRC (Cancer Therapy and Research Center) at UTHSCSA

San Antonio, Texas, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

April 10, 2018

Enrollment

ACTUAL participants

Conditions

Epithelial Ovarian CancerExtraovarian Peritoneal CancerFallopian Tube Carcinoma

Interventions

Denileukin Diftitox/SC Pegylated IFNα-2a

DRUG

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

NCT07432633

Colorectal CancerEpithelial Ovarian Cancer+3 more

View study

RECRUITINGPHASE2

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

NCT06290193

Ovarian CancerFallopian Tube Carcinoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

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