In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients With Resectable Pulmonary Metastases of Colorectal Cancers

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Diagnosis of Colorectal Carcinoma

• Presence of bilateral pulmonary metastases

• 3 or more lung lesions in total

• Age 70 years or less

• ECOG 0-2

• Absence of extra-pulmonary disease, except liver metastases suitable to curative treatment.

Locations
Other Locations
Canada
University Health Network, Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Jennifer K Lister
jennifer.lister@uhn.ca
416-340-4857
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2032-01-01
Participants
Target number of participants: 10
Treatments
Experimental: IVLP in single lung
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov

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