deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT00357448

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

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

Sponsor: National Cancer Institute (NCI)

Conditions Fallopian Tube Cancer Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mixed Epithelial Carcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Ovarian Undifferentiated Adenocarcinoma Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer
Interventions denileukin diftitox enzyme-linked immunosorbent assay flow cytometry intraperitoneal administration laboratory biomarker analysis
Updated 7 times since 2017 Last updated: May 13, 2019 Started: Apr 30, 2005 Primary completion: Nov 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Fallopian Tube Cancer and Ovarian Clear Cell Cystadenocarcinoma, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 7 data snapshots since 2005. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshotActive Not Recruiting~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2019 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  5. Jun 2018 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

▶ Show 2 earlier versions

  1. Feb 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Apr 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of Washington
Data source: University of Washington

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations