In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
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.