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

• ClinicalTrials.gov Identifier: NCT01114958
• Recruitment Status: Completed
• First Posted: May 3, 2010
• Last Update Posted: February 10, 2020
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Gregory Daniels, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Neoplasms; Neoplasm Metastasis	Drug: Cisplatin, Thiosulfate	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 3, 2009
• Actual Primary Completion Date: May 17, 2013
• Actual Study Completion Date: May 17, 2013

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Frequency of adverse events due to intra-arterial cisplatin administration [ Time Frame: 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 :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

University of California, San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Sponsors and Collaborators

University of California, San Diego

Investigators

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

More Information

• Responsible Party: Gregory Daniels, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01114958
• Other Study ID Numbers: UCSD 090772
• First Posted: May 3, 2010
• Last Update Posted: February 10, 2020
• Last Verified: February 2020

Keywords provided by Gregory Daniels, University of California, San Diego:

Lung cancer; Non-small cell lung cancer; Small-cell lung cancer; Lung metastases; Metastatic cancer; Stage IIIA; Stage IIIB; Stage III; Stage 3

Additional relevant MeSH terms:

Lung Neoplasms; Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Cisplatin; Antineoplastic Agents