Bone SarcomaPhase 1NCT02811523
In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma
A Phase 1 study testing Doxorubicin in people with Bone Sarcoma and Soft Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 64 years
- Conditions the study is for
- Bone Sarcoma, Soft Tissue Sarcoma, Pulmonary Metastases
- What is being tested?
- Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Hypersenstivity to doxorubicin
- Current participation in another therapeutic clinical trial
- Previous lung metastatectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto
Marcelo Cypel, M.D., 416-581-7773, marcelo.cypel@uhn.ca
About this study
Official title: In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients Undergoing Surgical Resection of Pulmonary Metastases of Bone and Soft Tissues Sarcomas
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.
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma, Pulmonary Metastases
- Being tested
- Doxorubicin
- Medical subject headings
- Bone Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Doxorubicin by In Vivo Lung Perfusion
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicin 5 mcg/ml | Experimental | Doxorubicin 5mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases Receives: Drug: Doxorubicin |
| Doxorubicin 7 mcg/ml | Experimental | Doxorubicin 7mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases Receives: Drug: Doxorubicin |
| Doxorubicin 9 mcg/ml | Experimental | Doxorubicin 9mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases Receives: Drug: Doxorubicin |
| Doxorubicin 7 mcg/ml - expansion | Experimental | Expansion group at ideal dose Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of IVLP at selected dose levels by acute lung injury findings
Measured: Up to 2 years
Maximal tolerated dose by using a titration design
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Cypel, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811523
- Sponsor's protocol ID
- 15-8820
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2016
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Lung Perfusion (IVLP) as an Adjuvant Treatment for Patients Undergoing Surgical Resection of Pulmonary Metastases of Bone and Soft Tissues Sarcomas
- ClinicalTrials.gov ID
- NCT02811523
- Acronym / sponsor ID
- 15-8820
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma, Pulmonary Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Doxorubicin 5 mcg/ml | Experimental | Drug: DoxorubicinDoxorubicin 5mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases |
| Doxorubicin 7 mcg/ml | Experimental | Drug: DoxorubicinDoxorubicin 7mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases |
| Doxorubicin 9 mcg/ml | Experimental | Drug: DoxorubicinDoxorubicin 9mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases |
| Doxorubicin 7 mcg/ml - expansion | Experimental | Drug: DoxorubicinExpansion group at ideal dose |
Who may qualify
- Ages
- 0 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinDoxorubicin by In Vivo Lung Perfusion | Drug | Doxorubicin 5 mcg/ml, Doxorubicin 7 mcg/ml, Doxorubicin 7 mcg/ml - expansion, Doxorubicin 9 mcg/ml |
Primary outcome
Safety of IVLP at selected dose levels by acute lung injury findings
Time frame: Up to 2 years
Maximal tolerated dose by using a titration design
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelo Cypel, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Doxorubicin in people with Bone Sarcoma and Soft Tissue Sarcoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo Cypel, M.D. (416-581-7773, marcelo.cypel@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of IVLP at selected dose levels by acute lung injury findings (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.