- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773889
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
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- CTRC (Cancer Therapy and Research Center) at UTHSCSA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Denileukin Diftitox/SC Pegylated IFNα-2A
Administration of Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 2 years when study terminated early
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tyler Curiel, MD, The University of Texas Health Science Center at San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Carcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferon alpha-2
- Denileukin diftitox
Other Study ID Numbers
- HSC20090233H
- OCR 09-01 (Other Identifier: UTHSCSA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epithelial Ovarian Cancer
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedFallopian Tube Cancer | Stage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnRecurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Recurrent Ovarian Epithelial Cancer | Recurrent Ovarian Germ Cell Tumor | Stage IIIA Ovarian Germ Cell Tumor | Stage IIIB Ovarian Germ Cell... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity CancerCanada
-
University of WashingtonNational Cancer Institute (NCI)CompletedFallopian Tube Cancer | Peritoneal Cavity Cancer | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial Cancer | Ovarian Mucinous Cystadenocarcinoma and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditions
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIIA Primary... and other conditionsUnited States
Clinical Trials on Denileukin Diftitox/SC Pegylated IFNα-2a
-
Vir Biotechnology, Inc.Alnylam PharmaceuticalsActive, not recruitingChronic Hepatitis BAustralia, Hong Kong, Korea, Republic of, Malaysia, New Zealand, Thailand
-
The Wistar InstituteNational Institute of Allergy and Infectious Diseases (NIAID); Hoffmann-La... and other collaboratorsCompleted
-
Arbutus Biopharma CorporationActive, not recruitingChronic Hepatitis bUnited States, Korea, Republic of, Hong Kong, Taiwan, Australia, Moldova, Republic of, Ukraine
-
M.D. Anderson Cancer CenterWithdrawn