Epithelial Ovarian CancerPhase 2NCT01773889
A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer
A Phase 2 study testing Denileukin Diftitox/SC Pegylated IFNα-2a in people with Epithelial Ovarian Cancer and Extraovarian Peritoneal Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma
- What is being tested?
- Denileukin Diftitox/SC Pegylated IFNα-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CTRC (Cancer Therapy and Research Center) at UTHSCSA
San Antonio, Texas, 78229
About this study
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, Extraovarian Peritoneal or Fallopian Tube Carcinoma or Ineligible for First-Line Therapy
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.
Read the 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
- Being tested
- Denileukin Diftitox/SC Pegylated IFNα-2a
- Keywords
- Epithelial Ovarian Cancer, FIGO (Int Federation of Gyn and Ob )Stage III or Stage IV, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma Failing
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denileukin Diftitox/SC Pegylated IFNα-2aDrug
Also called Ontak plus Pegylated IFNα-2a
| Study group | Role | What they receive |
|---|---|---|
| Denileukin Diftitox/SC Pegylated IFNα-2A | Experimental | Administration of Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A Receives: Drug: Denileukin Diftitox/SC Pegylated IFNα-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler Curiel, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773889
- Sponsor's protocol ID
- HSC20090233H
- Other IDs
- OCR 09-01
- Status last verified
- May 2013
- First submitted
- 14 Jan 2013
- Last updated
- 10 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Extraovarian Peritoneal or Fallopian Tube Carcinoma or Ineligible for First-Line Therapy
- ClinicalTrials.gov ID
- NCT01773889
- Acronym / sponsor ID
- HSC20090233H
- Keywords
- Epithelial Ovarian Cancer, FIGO (Int Federation of Gyn and Ob )Stage III or Stage IV, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma Failing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denileukin Diftitox/SC Pegylated IFNα-2A | Experimental | Drug: Denileukin Diftitox/SC Pegylated IFNα-2aAdministration of Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denileukin Diftitox/SC Pegylated IFNα-2aAlso: Ontak plus Pegylated IFNα-2a | Drug | Denileukin Diftitox/SC Pegylated IFNα-2A |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Curiel, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denileukin Diftitox/SC Pegylated IFNα-2a in people with Epithelial Ovarian Cancer and Extraovarian Peritoneal Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.