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

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms; Neoplasm Metastasis
• Intervention / Treatment: Drug: Cisplatin, Thiosulfate

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego Moores Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IA Cisplatin / IV Thiosulfate; Single-arm study	Drug: Cisplatin, Thiosulfate; Cisplatin (150 mg/m^2) is given as an intra-arterial bolus, once, on days 2 and 9 of treatment. Thiosulfate (9 g/m^2), is given concurrently with cisplatin as an intravenous push over 15-20 minutes followed by a 6-hour intravenous infusion of thiosulfate (12 g/m^2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events due to intra-arterial cisplatin administration	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.	One week after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Gregory Daniels, M.D., University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2009
• Primary Completion (Actual): May 17, 2013
• Study Completion (Actual): May 17, 2013

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; Lung cancer; Metastatic cancer; Stage III; Lung metastases; Small-cell lung cancer; Stage IIIA; Stage IIIB; Stage 3
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: UCSD 090772