In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

NCT02811523 | Recruiting Phase 1

• 1 other identifier: 15-8820
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Doxorubicin 5 mcg/ml

EXPERIMENTAL

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

Drug: Doxorubicin

Doxorubicin 7 mcg/ml

EXPERIMENTAL

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

Drug: Doxorubicin

Doxorubicin 9 mcg/ml

EXPERIMENTAL

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

Drug: Doxorubicin

Doxorubicin 7 mcg/ml - expansion

EXPERIMENTAL

Expansion group at ideal dose

Drug: Doxorubicin

Interventions

Doxorubicin DRUG

Doxorubicin by In Vivo Lung Perfusion

Doxorubicin 5 mcg/ml; Doxorubicin 7 mcg/ml; Doxorubicin 7 mcg/ml - expansion; Doxorubicin 9 mcg/ml

Eligibility Criteria

• Age: 0 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Soft Tissue or Osteogenic Sarcoma
• Presence of bilateral pulmonary metastases
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Canada

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Marcelo Cypel, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo Cypel, M.D.

CONTACT

416-581-7773; marcelo.cypel@uhn.ca

Jennifer Lister, BSc CCRP

CONTACT

416-340-4857; Jennifer.Lister@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: February 1, 2016
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)