Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
Conditions
Lung Neoplasms - Neoplasm Metastasis
Conditions: official terms
Lung Neoplasms - Neoplasm Metastasis - Neoplasms
Conditions: Keywords
Lung cancer, Non-small cell lung cancer, Small-cell lung cancer, Lung metastases, Metastatic cancer, Stage IIIA, Stage IIIB, Stage III, Stage 3
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cisplatin, Thiosulfate
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
University of California, San Diego Moores Cancer Center
La Jolla, California, United States
Status: Recruiting
Contact: Yuri Matusov - 858-246-0357 - matusov@ucsd.edu
Start Date
April 2010
Sponsors
University of California, San Diego
Source
University of California, San Diego
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page