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NCT01468896 · ClinicalTrials.gov registry record · Phase 1

Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery

A Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
23
Enrollment target
2
Study locations

NCT01468896 is a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01468896, a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
23 participants
Enrollment target
2
Study locations

Study Summary

This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white blood cells to kill tumor cells. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread Giving recombinant interleukin-12 together with cetuximab may kill more tumor cells.

Interventions

  • BIOLOGICAL Cetuximab
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Edodekin alfa

Study Locations (2)

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2011-10-26
Est. Completion 2026-03-19
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01468896

The ClinicalTrials.gov registry entry for NCT01468896 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.

NCT01468896 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Ohio.

Frequently Asked Questions

What is clinical trial NCT01468896 about?

NCT01468896 is a clinical study titled "Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery". This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be rem...

What is the current status of trial NCT01468896?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2011-10-26. Estimated completion is 2026-03-19.

What conditions does trial NCT01468896 study?

This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Unresectable Head and Neck Squamous Cell Carcinoma.

What interventions are being tested in trial NCT01468896?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Edodekin alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT01468896?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01468896 being conducted?

This trial has 2 study locations across District of Columbia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.