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

Phase 1

Completed

• Conditions: Neoplasm Metastasis; Lung Neoplasms
• Interventions: Drug: Cisplatin, Thiosulfate

• Registration Number: NCT01114958
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-03
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Primary Completion: 2013-05-17
• Study Completion: 2013-05-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IA Cisplatin / IV Thiosulfate	Cisplatin, Thiosulfate	Single-arm study

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events due to intra-arterial cisplatin administration	One week after treatment	To characterize the toxicity of intra-arterial supradose cisplatin with thiosulfate rescue when delivered as two doses, one week apart, for patients with primary lung tumors and/or lung metastases.

Secondary Outcome Measures

Name	Time	Method
Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin.	4 weeks after first dose of cisplatin
Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.	Once before treatment

Trial Locations

Locations (1)

University of California, San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States