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

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT01114958

Collaborator

(none)

Enrollment

Location

Arm

44.4

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Neoplasm Metastasis	Drug: Cisplatin, Thiosulfate	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Actual Study Start Date :

Sep 3, 2009

Actual Primary Completion Date :

May 17, 2013

Actual Study Completion Date :

May 17, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IA Cisplatin / IV Thiosulfate Single-arm study	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).

Arm

Intervention/Treatment

Experimental: IA Cisplatin / IV Thiosulfate

Single-arm study

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).

Outcome Measures

Primary Outcome Measures

Frequency of adverse events due to intra-arterial cisplatin administration [One week after treatment]
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.

Secondary Outcome Measures

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]
Angiographic delineation of the vascular structure of primary lung tumors and lung metastases. [Once before treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.