deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT00228358

Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine

A Phase I Study of Infusion of HER-2/Neu Specific T Cells in Patients With Advanced Stage HER-2/Neu Expressing Cancers Who Have Received a HER-2/Neu Vaccine

Sponsor: National Cancer Institute (NCI)

Conditions HER2-positive Breast Cancer Recurrent Breast Cancer Recurrent Non-small Cell Lung Cancer Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Stage IV Breast Cancer Stage IV Non-small Cell Lung Cancer Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor
Interventions cyclophosphamide denileukin diftitox ex vivo-expanded HER2-specific T cells flow cytometry immunoenzyme technique
Updated 6 times since 2017 Last updated: Nov 7, 2014 Started: Jun 30, 2003 Primary completion: May 31, 2011
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 HER2-positive Breast Cancer and Recurrent Breast Cancer, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 6 data snapshots since 2003. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 21 months · monthly snapshotCompleted

Change History

6 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 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Jun 2003

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