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ACTIVE NOT RECRUITING 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

NCT01468896 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01468896

The ClinicalTrials.gov registry entry for NCT01468896 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01468896 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Unresectable Head and Neck Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01468896?

The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Edodekin alfa (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01468896?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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