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

Primary Purpose

Lung Neoplasms, Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin, Thiosulfate
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Lung cancer, Non-small cell lung cancer, Small-cell lung cancer, Lung metastases, Metastatic cancer, Stage IIIA, Stage IIIB, Stage III, Stage 3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Diego Moores Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IA Cisplatin / IV Thiosulfate

Arm Description

Single-arm study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin.
Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.

Full Information

First Posted
April 28, 2010
Last Updated
February 6, 2020
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01114958
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2009 (Actual)
Primary Completion Date
May 17, 2013 (Actual)
Study Completion Date
May 17, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IA Cisplatin / IV Thiosulfate
Arm Type
Experimental
Arm Description
Single-arm study
Intervention Type
Drug
Intervention Name(s)
Cisplatin, Thiosulfate
Intervention Description
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).
Primary Outcome Measure Information:
Title
Frequency of adverse events due to intra-arterial cisplatin administration
Description
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.
Time Frame
One week after treatment
Secondary Outcome Measure Information:
Title
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
Title
Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.
Time Frame
Once before treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Daniels, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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