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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01114958
First received: April 28, 2010
Last updated: May 4, 2010
Last verified: April 2010

April 28, 2010
May 4, 2010
April 2010
October 2011   (final data collection date for primary outcome measure)
Frequency of adverse events due to intra-arterial cisplatin administration [ Time Frame: One week after treatment ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01114958 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Angiographic delineation of the vascular structure of primary lung tumors and lung metastases. [ Time Frame: Once before treatment ] [ Designated as safety issue: No ]
  • To determine radiographically 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 ] [ Designated as safety issue: No ]
  • To use angiography in delineating the vascular structure of primary lung tumors and lung metastases. [ Time Frame: Once before treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Neoplasms
  • Neoplasm Metastasis
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).
Experimental: IA Cisplatin / IV Thiosulfate
Single-arm study
Intervention: Drug: Cisplatin, Thiosulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Not Provided
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Yuri Matusov (858) 246-0357 matusov@ucsd.edu
United States
 
NCT01114958
UCSD 090772
Not Provided
William Read, M.D., University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: William Read, M.D. University of California, San Diego
University of California, San Diego
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP