Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
Recruitment status was Recruiting
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.
Drug: Cisplatin, Thiosulfate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases|
- Frequency of adverse events due to intra-arterial cisplatin administration [ Time Frame: One week after treatment ] [ Designated as safety issue: Yes ]To characterize the toxicity of intra-arterial supradose cisplatin with thiosulfate rescue when delivered as two doses, one week apart, for patients with primary lung tumors and/or lung metastases.
- Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin. [ Time Frame: 4 weeks after first dose of cisplatin ] [ Designated as safety issue: No ]
- Angiographic delineation of the vascular structure of primary lung tumors and lung metastases. [ Time Frame: Once before treatment ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: IA Cisplatin / IV Thiosulfate
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114958
|Contact: Yuri Matusov||(858) firstname.lastname@example.org|
|United States, California|
|University of California, San Diego Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Yuri Matusov 858-246-0357 email@example.com|
|Principal Investigator: William Read, M.D.|
|Principal Investigator:||William Read, M.D.||University of California, San Diego|