Previously Treated Childhood RhabdomyosarcomaPhase 2NCT00070109
Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
A Phase 2 study testing trabectedin and pharmacological study in people with Previously Treated Childhood Rhabdomyosarcoma and Recurrent Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 14 sites in 2 countries.
Trial summary
This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 12 months to 50 years
- Conditions the study is for
- Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma
- What is being tested?
- trabectedin and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2008to Dec 2013
- Phase
- Phase 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 12 months to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be greater than or equal to 12 months of age at the time of study entry and no more than 21 years of age when initially diagnosed with the malignancy to be treated on this protocol
- Histologically confirmed recurrent or refractory sarcoma tumors, including the following:
- Rhabdomyosarcoma
- Nonrhabdomyosarcomatous soft tissue sarcoma
- Ewing's sarcoma
- Measurable disease by imaging studies
Show all 58Show fewer
- Lesions assessable only by radionuclide scans are not considered measurable
- If the only measurable lesion has been previously irradiated, then that lesion must have shown evidence of an interim increase in size
- No significant amount of metastatic liver disease, defined as the following:
- Lesions occupying more than 25% of the liver by imaging and abnormal liver function tests or abnormal synthetic liver function
- Performance status - Lansky 50-100% (10 years of age and under)
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (transfusion allowed)
- No concurrent CYP3A4 inhibitors, including the following:
- Grapefruit juice
- Erythromycin
- Azithromycin
- Clarithromycin
- Rifampin and its analogs
- Fluconazole
- Ketoconazole
- Itraconazole
- Cimetidine
- Cannabinoids (marijuana or dronabinol)
- Leukotriene inhibitors used in asthma (e.g., zafirlukast, montelukast, or zileuton)
- Bilirubin no greater than upper limit of normal (ULN)
- Total alkaline phosphatase no greater than ULN
- Hepatic fraction alkaline phosphatase and 5 nucleotidase no greater than ULN
- SGOT and SGPT ≤ 2.5 times ULN
- Albumin ≥ 2.5 g/dL
- Gamma-glutamyl transferase < 2.5 times ULN
- Maximum creatinine based on age as follows:
- 0.8 mg/dL (5 years of age and under)
- 1.0 mg/dL (6 to 10 years of age)
- 1.2 mg/dL (11 to 15 years of age)
- 1.5 mg/dL (over 15 years of age)
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min
- No uncompensated congestive heart failure within the past 6 months
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 2 months after study participation
- No active uncontrolled infection
- Weight ≥ 15 kilograms
- More than 1 week since prior growth factors that support platelet or white blood cell number or function
- At least 7 days since prior biologic agents and recovered
- No prior allogeneic stem cell transplantation
- No other concurrent immunomodulating agents
- More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No more than 2 prior multi-agent chemotherapy regimens
- No other concurrent anticancer chemotherapy
- Concurrent steroids allowed
- At least 6 weeks since prior since prior extended radiotherapy and recovered
- No prior total body radiotherapy
- Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated*
- At least 7 days since prior enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin)
- No concurrent enzyme-inducing anticonvulsants
- No other concurrent investigational agents
Who cannot join
None listed.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States11 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Vermont
Burlington, Vermont, 05401
Childrens Memorial Hospital
Chicago, Illinois, 60614
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Children's Hospital Central California
Madera, California, 93636-8762
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
New York University Langone Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Seattle Children's Hospital
Seattle, Washington, 98105
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Canada3 sites
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8S 4L8
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcomas
This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743 (trabectedin).
II. Determine the toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
OUTLINE:
Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 21days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
- Conditions
- Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor
- Being tested
- trabectedin, pharmacological study
- Medical subject headings
- Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabectedinDrug
Also called Ecteinascidin, ET 743, Yondelis
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin 1.3 mg/m2 to assess feasibility in all patients | Experimental | Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level. Receives: Drug: trabectedin; Other: pharmacological study |
| Trabectedin 1.5 mg/m2 to assess feasibility in all patients | Experimental | Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment. Receives: Drug: trabectedin; Other: pharmacological study |
| Trabectedin at 1.5 mg/m2 to assess efficacy in Ewing sarcoma | Experimental | Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: trabectedin; Other: pharmacological study |
| Trabectedin at 1.5 mg/m2 - assess efficacy in rhabdomyosarcoma | Experimental | Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: trabectedin; Other: pharmacological study |
| Trabectedin 1.5 mg/m2 - assess efficacy in nonrhabdomyosarcoma | Experimental | Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: trabectedin; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (Complete Response [CR] and Partial Response [PR])
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Measured: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.
Number of Patients With Dose-Limiting Toxicity (DLT)
Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
Measured: 1 Cycle
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
Measured: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
Measured: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
Measured: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
Measured: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
Measured: From baseline up to168 hours after trabectedin infusion in course 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionDec 2013
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 Previously Treated Childhood RhabdomyosarcomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sylvain Baruchel, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070109
- Sponsor's protocol ID
- ADVL0221
- Other IDs
- NCI-2009-00357, CDR0000329999, COG-ADVL0221, U10CA098543
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2003
- Last updated
- 14 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Baruchel S, Pappo A, Krailo M, Baker KS, Wu B, Villaluna D, Lee-Scott M, Adamson PC, Blaney SM. A phase 2 trial of trabectedin in children with recurrent rhabdomyosarcoma, Ewing sarcoma and non-rhabdomyosarcoma soft tissue sarcomas: a report from the Children's Oncology Group. Eur J Cancer. 2012 Mar;48(4):579-85. doi: 10.1016/j.ejca.2011.09.027. Epub 2011 Nov 14.
PubMed 22088484
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00070109
- Acronym / sponsor ID
- ADVL0221
- Conditions
- Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Oct 2003 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
PRIMARY OBJECTIVES:
- Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743 (trabectedin).
II. Determine the toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
OUTLINE:
Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 21days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Trabectedin 1.3 mg/m2 to assess feasibility in all patients | Experimental | Drug: trabectedin, Other: pharmacological studyPatients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level. |
| Trabectedin 1.5 mg/m2 to assess feasibility in all patients | Experimental | Drug: trabectedin, Other: pharmacological studyPatients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment. |
| Trabectedin at 1.5 mg/m2 to assess efficacy in Ewing sarcoma | Experimental | Drug: trabectedin, Other: pharmacological studyPatients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. |
| Trabectedin at 1.5 mg/m2 - assess efficacy in rhabdomyosarcoma | Experimental | Drug: trabectedin, Other: pharmacological studyPatients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. |
| Trabectedin 1.5 mg/m2 - assess efficacy in nonrhabdomyosarcoma | Experimental | Drug: trabectedin, Other: pharmacological studyPatients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 12 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (58 listed)
- Patients must be greater than or equal to 12 months of age at the time of study entry and no more than 21 years of age when initially diagnosed with the malignancy to be treated on this protocol
- Histologically confirmed recurrent or refractory sarcoma tumors, including the following:
- Measurable disease by imaging studies
- No significant amount of metastatic liver disease, defined as the following:
- Performance status - Lansky 50-100% (10 years of age and under)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| trabectedinAlso: Ecteinascidin, ET 743, YondelisGiven IV | Drug | Trabectedin 1.3 mg/m2 to assess feasibility in all patients, Trabectedin 1.5 mg/m2 - assess efficacy in nonrhabdomyosarcoma, Trabectedin 1.5 mg/m2 to assess feasibility in all patients, Trabectedin at 1.5 mg/m2 - assess efficacy in rhabdomyosarcoma, Trabectedin at 1.5 mg/m2 to assess efficacy in Ewing sarcoma |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Trabectedin 1.3 mg/m2 to assess feasibility in all patients, Trabectedin 1.5 mg/m2 - assess efficacy in nonrhabdomyosarcoma, Trabectedin 1.5 mg/m2 to assess feasibility in all patients, Trabectedin at 1.5 mg/m2 - assess efficacy in rhabdomyosarcoma, Trabectedin at 1.5 mg/m2 to assess efficacy in Ewing sarcoma |
Primary outcome
Response (Complete Response [CR] and Partial Response [PR])
Time frame: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Number of Patients With Dose-Limiting Toxicity (DLT)
Time frame: 1 Cycle
Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22088484Baruchel S, Pappo A, Krailo M, Baker KS, Wu B, Villaluna D, Lee-Scott M, Adamson PC, Blaney SM. A phase 2 trial of trabectedin in children with recurrent rhabdomyosarcoma, Ewing sarcoma and non-rhabdomyosarcoma soft tissue sarcomas: a report from the Children's Oncology Group. Eur J Cancer. 2012 Mar;48(4):579-85. doi: 10.1016/j.ejca.2011.09.027. Epub 2011 Nov 14.
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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.
Sylvain Baruchel, MD principal investigator
Children's Oncology Group
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trabectedin and pharmacological study in people with Previously Treated Childhood Rhabdomyosarcoma and Recurrent Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 14 sites in 2 countries.
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 58 inclusion and 0 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, 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 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 27 Jan 2014). 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?
Response (Complete Response [CR] and Partial Response [PR]) (time frame: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.). The study lists 7 primary outcomes in all. 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 NCT00070109, 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 14 Sep 2018.