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
  Purpose

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 Intervention Phase
Lung Neoplasms
Neoplasm Metastasis
Drug: Cisplatin, Thiosulfate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: April 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114958

Contacts
Contact: Yuri Matusov (858) 246-0357 matusov@ucsd.edu

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

No publications provided

Responsible Party: William Read, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT01114958     History of Changes
Other Study ID Numbers: UCSD 090772
Study First Received: April 28, 2010
Last Updated: May 4, 2010
Health Authority: United States: Institutional Review Board

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:
Neoplasms
Lung 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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014