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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01114958
Recruitment Status : Unknown
Verified April 2010 by University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : May 3, 2010
Last Update Posted : May 5, 2010
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
Study Start Date : April 2010
Estimated Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

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).

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 ]

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114958

Contact: Yuri Matusov (858) 246-0357

United States, California
University of California, San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Yuri Matusov    858-246-0357   
Principal Investigator: William Read, M.D.         
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: William Read, M.D. University of California, San Diego

Responsible Party: William Read, M.D., University of California, San Diego Identifier: NCT01114958     History of Changes
Other Study ID Numbers: UCSD 090772
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: April 2010

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