In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients Undergoing Surgical Resection of Pulmonary Metastases of Bone and Soft Tissues Sarcomas

Sarcoma which has spread to the lungs is most often treated with surgery. Even with surgery, most patients will not be cured and will die from their disease, probably because of small cancer cells that are present in the lungs at the time of surgery, but cannot be seen or detected. It is for this reason that we are looking for a better treatment. Giving chemotherapy after surgery is generally not recommended because it has significant side effects and no benefit has been proven.

This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). This is a Phase I, non-randomized, dose escalation study that will act as a pilot study for a larger prospective, multicenter, controlled clinical trial. Patients who have bilateral disease will have one lung undergo IVLP and the other lung will remain untreated with the IVLP (the other lung will be treated as current standard of care - either surgery or radiation) as a control lung. The patients will undergo a posterolateral thoracotomy. Lung metastases will be identified by visualization or palpation. After surgical isolation of the lung by proximal control of pulmonary artery and veins, IVLP will be initiated. After 3 hours of IVLP, the lung metastases will be removed in the usual fashion. Patients will be cared for post-surgery according to institutional standards. The patients will be followed for up to 2 years. The primary endpoint is safety. Secondary endpoints include additional safety endpoints and efficacy.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Sarcoma; Pulmonary Metastases; Bone Sarcoma
• Intervention / Treatment: Drug: Doxorubicin

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Lister, BSc CCRP; Phone Number: 416-340-4857; Email: Jennifer.Lister@uhn.ca
• Study Contact Backup: Name: Marcelo Cypel, M.D.; Phone Number: 416-581-7773; Email: marcelo.cypel@uhn.ca

Study Locations

• Canada
  • Toronto, Canada
    • Recruiting
    • Princess Margaret Cancer Centre
    • Contact: Marcelo Cypel, M.D.; Phone Number: 416-581-7773; Email: marcelo.cypel@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Soft Tissue or Osteogenic Sarcoma
• Presence of bilateral pulmonary metastases
• 3 or more lung lesions in total
• Age less than 65 years
• ECOG 0-2
• Absence of extra-pulmonary disease
• Contralateral disease amenable to surgery or radiation
• All lung lesions in the lung to be treated with IVLP can be resected with wedge or segmental resections (non-IVLP treated lung will be treated with radiation or surgery 4-12 weeks prior to IVLP)

Exclusion Criteria:

• Patient has previously received more than 450 mg of doxorubicin
• Left Ventricular Ejection Fraction <50%
• History of significant pulmonary disease or pneumonitis
• Pregnant or lactating females
• Age 65 years or older, or less than 18 years
• Inability to understand the informed consent process
• Hypersenstivity to doxorubicin
• Current participation in another therapeutic clinical trial
• Previous lung metastatectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doxorubicin 5 mcg/ml; Doxorubicin 5mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin; Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 7 mcg/ml; Doxorubicin 7mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin; Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 9 mcg/ml; Doxorubicin 9mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin; Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 7 mcg/ml - expansion; Expansion group at ideal dose	Drug: Doxorubicin; Doxorubicin by In Vivo Lung Perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of IVLP at selected dose levels by acute lung injury findings	Up to 2 years
Maximal tolerated dose by using a titration design	Up to 2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Marcelo Cypel, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimated): June 23, 2016

Study Record Updates

• Last Update Posted (Estimated): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Bone Neoplasms; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Doxorubicin
• Other Study ID Numbers: 15-8820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No