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Completed

NCT Number: NCT01114958

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

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.

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Key information

Conditions

Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cisplatin, Thiosulfate

Drug

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).

Primary outcomes

  1. Frequency of adverse events due to intra-arterial cisplatin administration

    Time frame: 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 outcomes

  1. 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

  2. Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.

    Time frame: Once before treatment

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 3, 2010
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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