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Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of Head and Neck
NCT01275183 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-04 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01275183
The ClinicalTrials.gov registry entry for NCT01275183 describes a study currently listed as completed. It is categorized as Early 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 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Mexico Cancer Research Alliance, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT01275183 reports 1 study location spanning 1 distinct geographic area — top geographies include New Mexico. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01275183?
The interventions under investigation include: raltegravir and cisplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01275183?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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