NCT01114958

Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases

A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Lung Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Cisplatin, Thiosulfate	Cisplatin (150 mg/m\^2) is given as an intra-arterial bolus, once, on days 2 and 9 of treatment. Thiosulfate (9 g/m\^2), is given concurrently with cisplatin as an intravenous push over 15-20 minutes followed by a 6-hour intravenous infusion of thiosulfate (12 g/m\^2).

Timeline

• Start date: 2009-09-03
• Primary completion: 2013-05-17
• Completion: 2013-05-17
• First posted: 2010-05-03
• Last updated: 2020-02-10

Locations

1 site across 1 country: United States