Clinical trial NCT01114958: Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Neoplasms
Neoplasm Metastasis
Keywords: Lung cancer
Non-small cell lung cancer
Small-cell lung cancer
Lung metastases
Metastatic cancer
Stage IIIA
Stage IIIB
Stage III
Stage 3
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of adverse events due to intra-arterial cisplatin administration
timeFrame: One week after treatment
Secondary outcomes:
measure: Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin.
timeFrame: 4 weeks after first dose of cisplatin
measure: Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.
timeFrame: Once before treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Gregory Daniels, M.D.
role: PRINCIPAL_INVESTIGATOR
References: