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

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114958
• Other study ID #: UCSD 090772
• Status: Completed
• Phase: Phase 1
• Start date: September 3, 2009
• Est. completion date: May 17, 2013

Study information

• Verified date: February 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 17, 2013
• Est. primary completion date: May 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary lung cancer (any type) or dominant lung metastases from other primary cancers.

• Patients must have either measurable or evaluable disease.

• Karnofsky performance status = 70%.

• Greater than 18 years of age.

• Life expectancy > 3 months.

• 3 week elapse from previous cytotoxic therapy (except for erlotinib or hormonal therapy, which can be ongoing) with side effects improved to grade 2 or less, and no prior radiotherapy to the lung.

• Adequate organ function.

• Treated brain metastases, if present, with toxicities improved to grade 2 or less.

• Willingness and ability to sign a written informed consent.

Exclusion Criteria:

• Prior radiation to the largest lesion in the lung.

• Current pregnancy or breast-feeding.

• Unwillingness or inability to practice contraception.

• Renal insufficiency.

• Comorbidities of grade 3 or greater.

• Concurrent medical or psychiatric conditions as defined by the treating physician which would preclude safe performance of study procedures or compromise the ability of the patient to consent to study.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

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).

Locations

Country	Name	City	State
United States	University of California, San Diego Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events due to intra-arterial cisplatin administration	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.	One week after treatment
Secondary	Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin.		4 weeks after first dose of cisplatin
Secondary	Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.		Once before treatment