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In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

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ClinicalTrials.gov Identifier: NCT02811523
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : February 2016
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024


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




Primary Outcome Measures :
  1. Safety of IVLP at selected dose levels by acute lung injury findings [ Time Frame: Up to 2 years ]
  2. Maximal tolerated dose by using a titration design [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   up to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811523


Contacts
Contact: Marcelo Cypel, M.D. 416-581-7773 marcelo.cypel@uhn.ca
Contact: Jennifer Lister, BSc CCRP 416-340-4857 Jennifer.Lister@uhn.ca

Locations
Canada
Princess Margaret Cancer Centre Recruiting
Toronto, Canada
Contact: Marcelo Cypel, M.D.    416-581-7773    marcelo.cypel@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Marcelo Cypel, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02811523     History of Changes
Other Study ID Numbers: 15-8820
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Osteosarcoma
Neoplasm Metastasis
Sarcoma
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action