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

NCT01114958 | Completed Phase 1

• 1 other identifier: UCSD 090772
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  One week after treatment

Secondary Outcomes (2)

• Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin.

  4 weeks after first dose of cisplatin

• Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.

  Once before treatment

Study Arms (1)

IA Cisplatin / IV Thiosulfate

EXPERIMENTAL

Single-arm study

Drug: Cisplatin, Thiosulfate

Interventions

Cisplatin, Thiosulfate DRUG

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).

IA Cisplatin / IV Thiosulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Cisplatin; Thiosulfates

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Sulfates; Anions; Ions; Electrolytes; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Gregory Daniels, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 3, 2010
• Study Start: September 3, 2009
• Primary Completion: May 17, 2013
• Study Completion: May 17, 2013
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

US (1)