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

University of California San Diego

Status and phase

Completed

Phase 1

Conditions

Lung Neoplasms

Neoplasm Metastasis

Treatments

Drug: Cisplatin, Thiosulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT01114958

UCSD 090772

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.