Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2010 |
| Contact: | Yuri Matusov |
| Email: | matusov@ucsd.edu |
| Phone: | (858) 246-0357 |
A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary 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.
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.
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.
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