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

NCT01773889 | Terminated Phase 2 Results DMC

• 2 other identifiers: HSC20090233HOCR 09-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epithelial Ovarian Cancer; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma

Keywords

Epithelial Ovarian Cancer; FIGO (Int Federation of Gyn and Ob )Stage III or Stage IV; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma Failing

Outcome Measures

Primary Outcomes (1)

• Clinical Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR. Failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria.

  every 3 months until the date of first documented progression or date of death from any cause, assessed up to 2 years when study terminated early

Study Arms (1)

Denileukin Diftitox/SC Pegylated IFNα-2A

EXPERIMENTAL

Administration of Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A

Drug: Denileukin Diftitox/SC Pegylated IFNα-2a

Interventions

Denileukin Diftitox/SC Pegylated IFNα-2a DRUG

Also known as: Ontak plus Pegylated IFNα-2a

Denileukin Diftitox/SC Pegylated IFNα-2A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No chemotherapy in the 14 days prior or radiation therapy in the thirty days prior to initiation of treatment on this study
• No other concurrent chemotherapy, surgery or radiation therapy during this protocol except surgery or radiation therapy to control symptoms with concurrence of the principal investigator
• No contraindication to any study treatment
• No active major medical problems, including untreated or uncontrolled infections
• Beck Depression Index ≥15 within 30 days of study enrollment

You may not qualify if:

• 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
• Life expectancy less than six months
• Serum albumin \< 1.8 gm/dl
• Blood hemoglobin \< 8.5 gm/dl
• ECOG performance status\> 2
• Symptomatic coronary artery disease (including uncontrolled angina, congestive heart failure, and the like)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

CTRC (Cancer Therapy and Research Center) at UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: Tyler Curiel, MD
• Organization: The Cancer and Therapy Center at The University of Texas Health Science Center San Antonio

CURIELT@UTHSCSA.EDU

210-562-5287

Study Officials

• Tyler Curiel, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 23, 2013
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 10, 2018
• Results First Posted: July 2, 2013

Record last verified: 2013-05

Locations

US (1)