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

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Tyler Curiel, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01773889
First received: January 14, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma
Drug: Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, or Fallopian Tube Carcinoma Failing Ineligible for First-Line Therapy (OCR 09-01)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Clinical Response Rate [ Time Frame: every 3 months until the date of first documented progression or date of death from any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
    Although positive clinical response criteria are based on RECIST criteria, 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.


Enrollment: 2
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A Drug: Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a
Other Name: Ontak plus Pegylated IFNα-2a

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  • If of reproductive potential, a negative urine pregnancy test within 3 days of study enrollment, and agreement to use adequate contraception. Pregnancy testing will continue monthly while on treatment unless the subject is no longer able to become pregnant or there is sufficient justification otherwise
  • Not breast feeding
  • Life expectancy ≥ six months
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  • Serum albumin ≥ 1.8 gm/dl
  • Age ≥ 18 years
  • Acceptable baseline retinal examination within 30 days of study enrollment
  • No active substance abuse in the prior 6 months
  • Patients failing single agent denileukin diftitox in the ongoing trial "A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, Failing or Ineligible for First-Line Therapy" are eligible for this trial provided that three or more weeks have elapsed since their last denileukin diftitox infusion and they meet all eligibility criteria and successfully undergo all screening examinations for this trial.

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
  • 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)
  • Uncontrolled hypertension (diastolic BP consistently >100 mm Hg or systolic BP consistently >160 mm Hg on a regular basis)
  • Uncontrolled, symptomatic cardiac arrhythmia
  • Retinopathy associated with significant visual impairment
  • Beck Depression Index >15
  • Active substance abuse in the prior 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773889

Locations
United States, Texas
CTRC (Cancer Therapy and Research Center) at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Tyler Curiel
Investigators
Principal Investigator: Tyler Curiel, MD The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: Tyler Curiel, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01773889     History of Changes
Other Study ID Numbers: HSC20090233H, OCR 09-01
Study First Received: January 14, 2013
Results First Received: May 8, 2013
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Epithelial Ovarian Cancer
FIGO (International Federation of Gynecology and Obstetrics )Stage III or Stage IV
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma Failing

Additional relevant MeSH terms:
Carcinoma
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Denileukin diftitox
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014