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In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung

Sponsor
University Health Network, Toronto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05611034
Collaborator
(none)
10
Enrollment
1
Arm
110
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 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 With Resectable Pulmonary Metastases of Colorectal Cancers
Anticipated Study Start Date :
Oct 31, 2022
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: IVLP in single lung

Drug: Oxaliplatin
Oxaliplatin infusion in single lung via IVLP technique

Outcome Measures

Primary Outcome Measures

  1. safety as measured by acute lung injury findings [72 hours]

    Chest x- ray findings of pulmonary edema in the perfused lung in the first 72 hours (Grade 0-5).

Secondary Outcome Measures

  1. recurrence patterns [5 years]

  2. Incidence of pneumonia after procedure [72 hours]

  3. Incidence of ICU admission [72 hours]

  4. Incidence of mechanical ventilation [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Diagnosis of Colorectal Carcinoma

  2. Presence of bilateral pulmonary metastases

  3. 3 or more lung lesions in total

  4. Age 70 years or less

  5. ECOG 0-2

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

Exclusion Criteria:

  1. Patient has previously received more than 1000 mg of oxaliplatin

  2. Left Ventricular Ejection Fraction <50%

  3. History of significant pulmonary disease or pneumonitis

  4. Pregnant or lactating females

  5. Age 71 or older, or less than 18 years

  6. Inability to understand the informed consent process

  7. Hypersenstivity to oxaliplatin

  8. Patients with Heparin-induced thrombocytopenia (HIT)

  9. Patients who cannot receive cefazolin or methylprednisolone due to allergy or another reason can be included but will not receive the drug they cannot tolerate

  10. Current participation in another therapeutic clinical trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Marcelo K Cypel, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT05611034
Other Study ID Numbers:
  • 20-6152
First Posted:
Nov 9, 2022
Last Update Posted:
Nov 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto
IVLP
metastatic
Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Oxaliplatin

Study Results

No Results Posted as of Nov 9, 2022