In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

NCT ID: NCT02811523

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2030-09-30

Brief Summary

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.

Conditions

Bone Sarcoma; Soft Tissue Sarcoma; Pulmonary Metastases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxorubicin 5 mcg/ml

Doxorubicin 5mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

Doxorubicin by In Vivo Lung Perfusion

Doxorubicin 7 mcg/ml

Doxorubicin 7mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

Doxorubicin by In Vivo Lung Perfusion

Doxorubicin 9 mcg/ml

Doxorubicin 9mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

Doxorubicin by In Vivo Lung Perfusion

Doxorubicin 7 mcg/ml - expansion

Expansion group at ideal dose

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

Doxorubicin by In Vivo Lung Perfusion

Interventions

Doxorubicin

Doxorubicin by In Vivo Lung Perfusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo Cypel, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre

Toronto, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marcelo Cypel, M.D.

Role: CONTACT

marcelo.cypel@uhn.ca

416-581-7773

Jennifer Lister, BSc CCRP

Role: CONTACT

Jennifer.Lister@uhn.ca

416-340-4857

Facility Contacts

Marcelo Cypel, M.D.

Role: primary

marcelo.cypel@uhn.ca

416-581-7773

Other Identifiers

15-8820

Identifier Type: -

Identifier Source: org_study_id