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Fallopian Tube CancerPhase 1NCT00357448

Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer

A Phase 1 study testing denileukin diftitox, intraperitoneal administration and laboratory biomarker analysis in people with Fallopian Tube Cancer and Ovarian Clear Cell Cystadenocarcinoma, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox in treating patients with advanced refractory ovarian cancer, primary… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
denileukin diftitox, intraperitoneal administration and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Apr 2005to Nov 2009
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Patients with a histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or epithelial fallopian tube carcinoma
  • Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, transitional cell carcinoma, and mixed epithelial carcinoma
  • Patients with advanced stage refractory ovarian carcinoma: patients unable to achieve first complete remission (CR) with first or second line chemotherapy OR patients with disease relapse after achieving second CR
  • Patients must be 30 days out from last chemotherapy; previous chemotherapy must include a platinumbased regimen and paclitaxel (Taxol)
  • Patients must have undergone primary debulking surgery
  • Patients must have a peritoneal catheter suitable for I.P. infusion
Show all 16Show fewer
  • White blood cell count (WBC) > 3.0 THOU/ul
  • Serum creatinine =< 2.5 mg/dL
  • ALT =< 2.5 x upper limit of normal
  • AST =< 2.5 x upper limit of normal
  • Total bilirubin =< 2.0 x upper limit of normal
  • Albumin >= 3.0 g/dL
  • Subjects must have a Performance Status Score (Zubrod/SWOG Scale) =< 2
  • Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
  • Lymphocytes > 1.0 THOU/ul
  • Platelets >= 100 THOU/ul

Who cannot join

  • Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2
  • Known history of hypersensitivity to diphtheria toxin or IL-2
  • Moderate (symptomatic requiring the use of diuretics) or severe (symptomatic requiring paracentesis or other invasive intervention) ascites
  • Active autoimmune disease
  • Known history of pulmonary disease except controlled asthma
  • Known history significant cardiac disease
  • Concurrent malignancy requiring active treatment
  • Clinical or radiological evidence of acute bowel obstruction within 30 days of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK® Administered to Patients With Advanced Stage Ovarian Cancer

RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox in treating patients with advanced refractory ovarian cancer, primary peritoneal carcinoma, or epithelial fallopian tube cancer.

Read the detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose of intraperitoneal administration of ONTAK. SECONDARY OBJECTIVES: I. To evaluate the change in the number of Tregs in the peritoneum with the administration of ONTAK. II. To evaluate the change in the number of Tregs in the peripheral blood with the administration of ONTAK. III. To assess the clinical impact of ONTAK on tumor burden by serial measurements of CA-125. IV. To assess the level of circulating cytokines IL-2, IL-6, IL-10, TGF-beta2, and TNF-alpha in the peritoneum and peripheral blood before and after I.P. ONTAK. OUTLINE: This is a dose escalation study. Patients receive intraperitoneal denileukin diftitox over at least 15 minutes on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of denileukin diftitox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After the completion of study treatment, patients are followed up at 1 and 2 weeks, monthly for 3 months, and then at 6 months.

Being tested
denileukin diftitox, intraperitoneal administration, laboratory biomarker analysis, enzyme-linked immunosorbent assay, flow cytometry
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • denileukin diftitoxBiological

    Also called DAB389 interleukin-2, DAB389 interleukin-2 immunotoxin, DAB389-IL2, DAB389IL-2

    Given IP at 3 dose levels: 5mcg/kg of ONTAK, 15mcg/kg of ONTAK, or 25mcg/kg of ONTAK

  • intraperitoneal administrationProcedure or surgery

    After completion of I.P. normal saline infusion, the I.P. catheter will be capped and patients will be turned/rotated for 1 hour to help facilitate I.P. bathing w/ONTAK; patients will be turned/rotated every 15 minutes in 4 different positions for a total of 1 hour

  • laboratory biomarker analysisOther

    Correlative studies

  • enzyme-linked immunosorbent assayOther

    Also called ELISA

    Correlative studies

  • flow cytometryOther

    Correlative studies

Study groups in NCT00357448
Study groupRoleWhat they receive
Arm IExperimentalPatients receive intraperitoneal denileukin diftitox over at least 15 minutes on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: denileukin diftitox; Procedure: intraperitoneal administration; Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Other: flow cytometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and toxicity profile as assessed by the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events version 3.0

    Measured: From baseline

  2. MTD

    Measured: From baseline

Secondary outcomes (3)

  1. Efficacy of ONTAK defined as a 25% reduction in the number of Tregs in either the peripheral blood and/or in the peritoneal cavity

    Measured: From baseline

  2. Clinical impact on course of disease as assessed by serum CA-125 measurements

    Measured: At baseline and at months 1, 2, 3, and 6

  3. Changes in circulating cytokines IL-2, IL-6, IL-10, TGF-beta2, and TNF-alpha in the peripheral blood and at the site of disease as measured by ELISA

    Measured: Pre- and post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2006 (estimated)
  2. Study startApr 2005
  3. Primary completionNov 2009

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00357448
Sponsor's protocol ID
6193
Other IDs
NCI-2010-00832
Status last verified
May 2019
First submitted
26 Jul 2006
Last updated
14 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Liao JB, Jejurikar NS, Hitchcock-Bernhardt KM, Gwin WR, Reichow JL, Dang Y, Childs JS, Coveler AL, Swensen RE, Goff BA, Disis ML, Salazar LG. Intraperitoneal immunotherapy with denileukin diftitox (ONTAK) in recurrent refractory ovarian cancer. Gynecol Oncol. 2024 Dec;191:74-79. doi: 10.1016/j.ygyno.2024.09.019. Epub 2024 Oct 2.

    PubMed 39362046

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing denileukin diftitox, intraperitoneal administration and laboratory biomarker analysis in people with Fallopian Tube Cancer and Ovarian Clear Cell Cystadenocarcinoma, run by University of Washington 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 14 May 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and toxicity profile as assessed by the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events version 3.0 (time frame: From baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00357448, which also lists 1 linked publication.

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 14 May 2019.

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