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Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
NCT01114958 · View on ClinicalTrials.gov ↗
Study Summary
This phase I study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at least one lung lesion large enough of characterize angiographically. All patients will first undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2 consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response as measured on week 4. This pilot study will also determine how technically feasible it is to locate the blood supply to these tumors and deliver cisplatin. If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.
Conditions Studied
Interventions
- DRUG Cisplatin, Thiosulfate
Study Locations (1)
California
- University of California, San Diego Moores Cancer Center — La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-09-03 |
| Est. Completion | 2013-05-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01114958
The ClinicalTrials.gov registry entry for NCT01114958 describes a study currently listed as completed. 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 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 823 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 1 intervention — of which Cisplatin, Thiosulfate 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: NCT01114958 reports 1 study location spanning 1 distinct geographic area — top geographies include California. 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 NCT01114958 about?
NCT01114958 is a clinical study titled "Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases". This phase I study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at least one lung lesion large enough of characterize angiographically. All patients will first undergo a CT arteriogram of th...
What is the current status of trial NCT01114958?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2009-09-03. Estimated completion is 2013-05-17.
What conditions does trial NCT01114958 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Lung Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01114958?
The interventions under investigation include: Cisplatin, Thiosulfate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01114958?
This trial is sponsored by University of California, San Diego, which has 823 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01114958 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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