New method to deliver chemotherapy directly into the lungs for sarcoma patients
In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients Undergoing Surgical Resection of Pulmonary Metastases of Bone and Soft Tissues Sarcomas
This study is testing a new way to deliver chemotherapy directly into the lungs during surgery for sarcoma patients to see if it can better target hidden cancer cells and improve their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 0 Years to 64 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation, doxorubicin, chemotherapy |
| Locations | 1 site (Toronto) |
| Trial ID | NCT02811523 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel technique called In Vivo Lung Perfusion (IVLP) to deliver chemotherapy directly into the lungs during surgery for patients with sarcoma that has spread to the lungs. The goal is to target microscopic cancer cells that may remain undetected at the time of surgery, potentially improving patient outcomes. This Phase I, non-randomized, dose escalation study will serve as a pilot for future larger studies. The intervention involves administering doxorubicin directly into the lungs to minimize side effects on other organs.
Who should consider this trial
Good fit: Ideal candidates are patients under 65 years old with bilateral pulmonary metastases from soft tissue or osteogenic sarcoma and multiple lung lesions.
Not a fit: Patients over 65 years old, those with significant pulmonary disease, or those who have previously received high doses of doxorubicin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with pulmonary metastases from sarcoma.
How similar studies have performed: While this approach is novel, similar targeted delivery methods in other cancers have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto
- Princess Margaret Cancer Centre — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: Marcelo Cypel, MD — University Health Network, Toronto
- Study coordinator: Marcelo Cypel, M.D.
- Email: marcelo.cypel@uhn.ca
- Phone: 416-581-7773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.