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

Completed · Phase 1

Conditions studied: Lung Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT01114958

Run by

University of California, San Diego

People needed

8

Starts

2009-09-03

Expected to finish

2013-05-17

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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