NCT02811523 In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma
| NCT ID | NCT02811523 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Health Network, Toronto |
| Condition | Bone Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2016-02 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 17 participants in total. It began in 2016-02 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marcelo Cypel, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT02811523 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 64 Years, studying Bone Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02811523 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02811523 currently recruiting?
Yes, NCT02811523 is actively recruiting participants. Contact the research team at marcelo.cypel@uhn.ca for enrollment information.
Where is the NCT02811523 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT02811523 clinical trial?
NCT02811523 is sponsored by University Health Network, Toronto. The principal investigator is Marcelo Cypel, MD at University Health Network, Toronto. The trial plans to enroll 17 participants.