In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02811523

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Sarcoma Soft Tissue Sarcoma Pulmonary Metastases	Drug: Doxorubicin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

11 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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 11 mcg/ml Doxorubicin 11mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 13 mcg/ml Doxorubicin 13mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 15 mcg/ml Doxorubicin 15mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 17 mcg/ml Doxorubicin 17mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin Doxorubicin by In Vivo Lung Perfusion
Experimental: Doxorubicin 20 mcg/ml Doxorubicin 20mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases	Drug: Doxorubicin Doxorubicin by In Vivo Lung Perfusion

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto		Canada

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Marcelo Cypel, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT02811523

Other Study ID Numbers:

15-8820

First Posted:

Jun 23, 2016

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2022