Pulmonary Relapse of OsteosarcomaPhase 2NCT01650090
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
A Phase 2 study testing Inhaled Lipid Cisplatin (ILC) in people with Pulmonary Relapse of Osteosarcoma, run by Eleison Pharmaceuticals LLC. at 15 sites in United States.
Trial summary
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pulmonary Relapse of Osteosarcoma
- What is being tested?
- Inhaled Lipid Cisplatin (ILC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2012to Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of osteosarcoma metastatic to the lung(s). (First or second pulmonary recurrence(s) removed by surgery, and previous second-line systemic chemotherapy is allowed).
- Patients must be macroscopically disease free following pulmonary metastectomy of a single or multiple lesions. Complete remission surgically (free of macroscopic disease) is required. Pleural disruption and/or microscopic positive margins are allowed.
- Age ≥13 years.
- Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia.
- Patients must have an ECOG performance status of 0-2. (Lansky score of 50-100 if < 16 years old).
- Patients must have recovered sufficiently from surgery and have adequate airflow and pulmonary reserve. This decision should be at the investigator's discretion taking into consideration pre-surgery pulmonary function. (As a guideline: adequate airflow defined by a measured Forced Expiratory Volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/FVC ratio of 65% or greater).
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- Patients must have adequate renal function as defined by a serum creatinine of ≤ 1.5 mg/dl.
- Patients must have adequate liver function as defined by total bilirubin of ≤ 1.5 mg/dl and ALT or AST < 2.5 times the institution's upper normal limit.
- Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3.
- Signed informed consent including, where applicable, the consent of the patient's legal guardian.
Who cannot join
- Current extrapulmonary disease.
- Current macroscopic pulmonary lesions.
- Greater than 2 pulmonary recurrences.
- Greater than 4 weeks since thoracotomy rendering patient free of macroscopic disease.
- Females who are pregnant or breast-feeding.
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.
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- Contraindication to or unwillingness to undergo multiple CT scans and chest X-rays.
- Unwillingness or inability to comply with the study protocol for any other reason.
- Participation in an investigational drug or device study or treatment with any anti-neoplastic agent within 14 days of the first day of dosing on this study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Stanford University Medical Center
Palo Alto, California, 94304
Mayo Clinic
Rochester, Minnesota, 55905
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
The Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.
Read the detailed description
ILC is a novel formulation of cisplatin, designed for inhalation by nebulization. The anticipated pulmonary benefits of ILC over systemic cisplatin therapy are threefold:
- Increased local cisplatin concentrations
- Sustained release of cisplatin in the lungs
- Minimal systemic exposure to cisplatin
In this study, patients currently in surgical complete remission (CR) following one or two prior relapses of osteosarcoma involving pulmonary disease will be treated with ILC every two weeks for up to one year. ILC will be administered via nebulization.
- Conditions
- Pulmonary Relapse of Osteosarcoma
- Being tested
- Inhaled Lipid Cisplatin (ILC)
- Keywords
- Pulmonary relapse, Osteosarcoma, Lung metastases, Pediatric osteosarcoma, Inhaled chemotherapy, Inhaled Lipid Cisplatin
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Lipid Cisplatin (ILC)Drug
Also called Cisplatin, Lipid cisplatin complex
ILC is provided as cisplatin in a lipid complex suspended in a saline solution. Every two weeks, the patient will receive 36 mg/m2 (measured as concentration of cisplatin) of ILC via nebulization. Treatment may continue for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| ILC | Experimental | Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation. Receives: Drug: Inhaled Lipid Cisplatin (ILC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Relapse Free Interval (RFI)
Observed relapse free interval (RFI) will be compared to historical controls. Relapse free interval is defined as the time of diagnosis of the previous relapse to time of diagnosis of the new relapse.
Measured: At relapse, estimated at 6-12 months average.
Secondary outcomes (2)
Median, 1, 2 and 5 year Overall Survival (OS)
The percentage of patients alive at 1, 2 and 5 years and the median overall survival.
Measured: 1, 2 and 5 Years
Median, 1, 2 and 5 year Event Free Survival (EFS)
The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.
Measured: 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Relapse of OsteosarcomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleison Pharmaceuticals LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Gorlick, MD, Principal investigator, Children's Hospital at MontefioreForrest H Anthony, MD, PhD, Study director, Eleison Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650090
- Sponsor's protocol ID
- EP-ILC-201
- Status last verified
- Aug 2019
- First submitted
- 20 Jul 2012
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
- ClinicalTrials.gov ID
- NCT01650090
- Acronym / sponsor ID
- EP-ILC-201
- Conditions
- Pulmonary Relapse of Osteosarcoma
- Keywords
- Pulmonary relapse, Osteosarcoma, Lung metastases, Pediatric osteosarcoma, Inhaled chemotherapy, Inhaled Lipid Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eleison Pharmaceuticals LLC.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 26 Jul 2012 (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.
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.
Detailed description
ILC is a novel formulation of cisplatin, designed for inhalation by nebulization. The anticipated pulmonary benefits of ILC over systemic cisplatin therapy are threefold:
- Increased local cisplatin concentrations
- Sustained release of cisplatin in the lungs
- Minimal systemic exposure to cisplatin
In this study, patients currently in surgical complete remission (CR) following one or two prior relapses of osteosarcoma involving pulmonary disease will be treated with ILC every two weeks for up to one year. ILC will be administered via nebulization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILC | Experimental | Drug: Inhaled Lipid Cisplatin (ILC)Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- History of osteosarcoma metastatic to the lung(s). (First or second pulmonary recurrence(s) removed by surgery, and previous second-line systemic chemotherapy is allowed).
- Patients must be macroscopically disease free following pulmonary metastectomy of a single or multiple lesions. Complete remission surgically (free of macroscopic disease) is required. Pleural disruption and/or microscopic positive margins are allowed.
- Age ≥13 years.
- Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia.
- Patients must have an ECOG performance status of 0-2. (Lansky score of 50-100 if < 16 years old).
Key exclusion criteria (9 listed)
- Current extrapulmonary disease.
- Current macroscopic pulmonary lesions.
- Greater than 2 pulmonary recurrences.
- Greater than 4 weeks since thoracotomy rendering patient free of macroscopic disease.
- Females who are pregnant or breast-feeding.
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 |
|---|---|---|
| Inhaled Lipid Cisplatin (ILC)Also: Cisplatin, Lipid cisplatin complexILC is provided as cisplatin in a lipid complex suspended in a saline solution. Every two weeks, the patient will receive 36 mg/m2 (measured as concentration of cisplatin) of ILC via nebulization. Treatment may continue for up to 1 year. | Drug | ILC |
Primary outcome
Observed Relapse Free Interval (RFI)
Time frame: At relapse, estimated at 6-12 months average.
Observed relapse free interval (RFI) will be compared to historical controls. Relapse free interval is defined as the time of diagnosis of the previous relapse to time of diagnosis of the new relapse.
2 secondary outcomes
Median, 1, 2 and 5 year Overall Survival (OS)
Time frame: 1, 2 and 5 Years
Median, 1, 2 and 5 year Event Free Survival (EFS)
Time frame: 1, 2 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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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. This study is not recruiting at the moment.
Richard Gorlick, MD principal investigator
Children's Hospital at Montefiore
Forrest H Anthony, MD, PhD study director
Eleison Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Lipid Cisplatin (ILC) in people with Pulmonary Relapse of Osteosarcoma, run by Eleison Pharmaceuticals LLC. at 15 sites in United States.
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 10 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: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Relapse Free Interval (RFI) (time frame: At relapse, estimated at 6-12 months average.). 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 7 Aug 2019.