Osteosarcoma MetastaticPhase 1/2NCT00102531
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
A Phase 1/2 study testing Cisplatin liposomal in people with Osteosarcoma Metastatic, run by Insmed Incorporated at 2 sites in United States.
Trial summary
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Osteosarcoma Metastatic
- What is being tested?
- Cisplatin liposomal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jan 2005to 17 Mar 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
- Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
- Measureable pulmonary metastases
- Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
- ECOG performance status of 0, 1 or 2
- FEV1 of 50% or greater of predicted value
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- FEV1/FVC ratio of 65% or greater
- Serum creatinine of ≤ 1.5 mg/dl
- Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT < 2.5 times upper normal limit
- ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3
Who cannot join
- Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
- Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
- Concurrent systemic chemotherapy
- Greater than Grade 2 pulmonary toxicity
- Pulmonary atelectasis
- Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy
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- Concurrent serious infections
- Unstable or serious concurrent medical condition
- Recent major surgery or thoracic radiation therapy or chemotherapy
- Significant pulmonary fibrosis secondary to prior radiation
- Major ventilatory distribution abnormalities
- Osteosarcoma secondary to radiation or premalignant conditions
- History of prior malignancy
- Low grade osteosarcoma, parosteal or periosteal sarcoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
The Albert Einstein College of Medicine Montefiore Medical Center
New York, New York, 10467
About this study
Official title: Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.
- Conditions
- Osteosarcoma Metastatic
- Being tested
- Cisplatin liposomal
- Keywords
- Osteosarcoma, relapsed, progressive, metastatic, lung
- Medical subject headings
- Osteosarcoma, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin liposomalDrug
Also called SLIT Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin liposomal 24 mg/m2 | Experimental | Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles. Receives: Drug: Cisplatin liposomal |
| Cisplatin liposomal 36 mg/m2 | Experimental | The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2 Receives: Drug: Cisplatin liposomal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
Measured: 4 to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2005 (estimated)
- Study start12 Jan 2005
- Primary completionMar 2008
- Study completion17 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteosarcoma MetastaticStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renu Gupta, MD, Study chair, Transave Inc.Richard Gorlick, MD, Principal investigator, The Albert Einstein College of Medicine Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102531
- Sponsor's protocol ID
- TR02-2421
- Status last verified
- Jul 2017
- First submitted
- 29 Jan 2005
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chou AJ, Gupta R, Bell MD, Riewe KO, Meyers PA, Gorlick R. Inhaled lipid cisplatin (ILC) in the treatment of patients with relapsed/progressive osteosarcoma metastatic to the lung. Pediatr Blood Cancer. 2013 Apr;60(4):580-6. doi: 10.1002/pbc.24438. Epub 2012 Dec 19.
PubMed 23255417
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
- ClinicalTrials.gov ID
- NCT00102531
- Acronym / sponsor ID
- TR02-2421
- Conditions
- Osteosarcoma Metastatic
- Keywords
- Osteosarcoma, relapsed, progressive, metastatic, lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2005 (actual)
- Primary completion
- Mar 2008 (actual)
- Study completion
- 17 Mar 2008 (actual)
- First posted
- 31 Jan 2005 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin liposomal 24 mg/m2 | Experimental | Drug: Cisplatin liposomalInhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles. |
| Cisplatin liposomal 36 mg/m2 | Experimental | Drug: Cisplatin liposomalThe study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2 |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
- Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
- Measureable pulmonary metastases
- Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
- ECOG performance status of 0, 1 or 2
Key exclusion criteria (14 listed)
- Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
- Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
- Concurrent systemic chemotherapy
- Greater than Grade 2 pulmonary toxicity
- Pulmonary atelectasis
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 |
|---|---|---|
| Cisplatin liposomalAlso: SLIT Cisplatin | Drug | Cisplatin liposomal 24 mg/m2, Cisplatin liposomal 36 mg/m2 |
Primary outcome
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
Time frame: 4 to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23255417Chou AJ, Gupta R, Bell MD, Riewe KO, Meyers PA, Gorlick R. Inhaled lipid cisplatin (ILC) in the treatment of patients with relapsed/progressive osteosarcoma metastatic to the lung. Pediatr Blood Cancer. 2013 Apr;60(4):580-6. doi: 10.1002/pbc.24438. Epub 2012 Dec 19.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Renu Gupta, MD study chair
Transave Inc.
Richard Gorlick, MD principal investigator
The Albert Einstein College of Medicine Montefiore Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cisplatin liposomal in people with Osteosarcoma Metastatic, run by Insmed Incorporated at 2 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 14 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 1 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. (time frame: 4 to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102531, which also lists 1 linked publication.
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 1 Aug 2017.