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NCT01275183 · ClinicalTrials.gov registry record · Early Phase 1

Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of Head and Neck

A Early Phase 1 study of Head and Neck Cancer, sponsored by New Mexico Cancer Research Alliance.

Completed
Registry status
Early Phase 1
Development phase
5
Enrollment target
1
Study location

NCT01275183 is a Early Phase 1 study of Head and Neck Cancer that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 5 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01275183, a Early Phase 1 study of Head and Neck Cancer, has completed, sponsored by New Mexico Cancer Research Alliance.

COMPLETED
Registry status
Early Phase 1
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and after cisplatin-raltegravir. The investigators will investigate immunohistochemical expression changes of γH2AX, Chk2, and Annexin V, three biomarkers of DNA damage and apoptosis. The study is designed to identify an intermediate signal of the potentiation of cisplatin chemotherapy by raltegravir in HNSCC, which will justify a future phase I/II study.

Conditions Studied

Interventions

  • DRUG raltegravir and cisplatin

Study Locations (1)

New Mexico

  • University of New Mexico Cancer Center - Albuquerque

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2010-12
Est. Completion 2015-04
Phase Early Phase 1

What the Registry Record Tells You About NCT01275183

The ClinicalTrials.gov registry entry for NCT01275183 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower). The listed sponsor is New Mexico Cancer Research Alliance, which has 66 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which raltegravir and cisplatin is the first listed.

NCT01275183 reports 1 study location spanning 1 distinct geographic area - top geographies include New Mexico.

Frequently Asked Questions

What is clinical trial NCT01275183 about?

NCT01275183 is a clinical study titled "Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of Head and Neck". The proposed study is a first-in-human pilot of a novel anti-cancer strategy: Metnase inhibition to potentiate DNA damaging chemotherapy. The investigators will conduct serial tumor biopsies in subjects with HNSCC at three timepoints: baseline, after cisplatin, and after cisplatin-raltegravir. The i...

What is the current status of trial NCT01275183?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2010-12. Estimated completion is 2015-04.

What conditions does trial NCT01275183 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT01275183?

The interventions under investigation include: raltegravir and cisplatin (DRUG).

Who is sponsoring clinical trial NCT01275183?

This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01275183 being conducted?

This trial has 1 study location across New Mexico. 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.