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.
Checked against the public recordLast updated Feb 10, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of California, San Diego
- Interventions being studied
- Drug: Cisplatin, Thiosulfate
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California, San Diego Moores Cancer CenterLa Jolla, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 10, 2020. Always confirm current availability with the study team.