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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Expression changes of three selected tumor biomarkers (DNA damage and apoptosis) will be measured at baseline, after cisplatin alone, and after raltegravir-cisplatin. Tumor biomarkers include pChk2, Annexin V, and metnase.

Conditions Studied

Head and Neck Cancer

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
New Mexico Cancer Research Alliance

66 total trials

What the finished NCT01275183 record still lists

NCT01275183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Head and Neck Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01275183's enrollment target sits among peer trials

5 244th of 250 higher than 6 of 250 other Head and Neck Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01275183, the US trial registry maintained by the National Library of Medicine. NCT01275183 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.