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A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasms, Neoplasm Metastasis

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Trial Information

A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of adverse events due to intra-arterial cisplatin administration

Outcome 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.

Outcome Time Frame:

One week after treatment

Safety Issue:

Yes

Principal Investigator

William Read, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Institutional Review Board

Study ID:

UCSD 090772

NCT ID:

NCT01114958

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Lung Neoplasms
  • Neoplasm Metastasis
  • Lung cancer
  • Non-small cell lung cancer
  • Small-cell lung cancer
  • Lung metastases
  • Metastatic cancer
  • Stage IIIA
  • Stage IIIB
  • Stage III
  • Stage 3
  • Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location

University of California, San Diego Moores Cancer CenterSan Diego, California  92093