ClinicalTrials.gov
ClinicalTrials.gov Menu

Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00070109
Recruitment Status : Completed
First Posted : October 7, 2003
Results First Posted : January 27, 2014
Last Update Posted : September 29, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma
Peripheral Primitive Neuroectodermal Tumor
Interventions: Drug: trabectedin
Other: pharmacological study

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients

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.

trabectedin: Given IV

pharmacological study: Correlative studies

Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients

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.

trabectedin: Given IV

Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma

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.

trabectedin: Given IV

Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma

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.

trabectedin: Given IV

Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma

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.

trabectedin: Given IV


Participant Flow:   Overall Study
    Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients   Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients   Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma   Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma   Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma
STARTED   8   6   8   20   8 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   8   6   8   20   8 
Death                1                1                0                0                1 
Lack of Efficacy                6                4                5                15                5 
Physician Decision                1                0                0                0                0 
Withdrawal by Subject                0                1                1                0                0 
Adverse Event                0                0                2                4                2 
removed from prot thpy prior to chemo                0                0                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients

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.

trabectedin: Given IV

pharmacological study: Correlative studies

Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients

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.

trabectedin: Given IV

Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma

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.

trabectedin: Given IV

Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma

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.

trabectedin: Given IV

Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma

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.

trabectedin: Given IV

Total Total of all reporting groups

Baseline Measures
   Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients   Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients   Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma   Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma   Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   6   8   20   8   50 
Age 
[Units: Years]
Median (Full Range)
 18.5 
 (8 to 24) 
 15.5 
 (8 to 21) 
 16 
 (8 to 20) 
 14.5 
 (4 to 22) 
 16 
 (8 to 21) 
 15.5 
 (4 to 24) 
Gender 
[Units: Participants]
           
Female   1   2   3   11   2   19 
Male   7   4   5   9   6   31 
Ethnicity (NIH/OMB) 
[Units: Participants]
           
Hispanic or Latino   0   1   0   3   3   7 
Not Hispanic or Latino   8   5   0   16   5   34 
Unknown or Not Reported   0   0   8   1   0   9 
Race (NIH/OMB) 
[Units: Participants]
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   0   0   1   1   0   2 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   1   0   0   5   1   7 
White   6   6   7   12   7   38 
More than one race   0   0   0   0   0   0 
Unknown or Not Reported   1   0   0   2   0   3 
Region of Enrollment 
[Units: Participants]
           
United States   5   6   5   19   8   43 
Canada   3   0   3   1   0   7 


  Outcome Measures

1.  Primary:   Response (Complete Response [CR] and Partial Response [PR])   [ Time Frame: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first. ]

2.  Primary:   Number of Patients With Dose-Limiting Toxicity (DLT)   [ Time Frame: 1 Cycle ]

3.  Secondary:   Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method   [ Time Frame: At baseline, at 1, 8, 23, 24, 26, 30, 96, and 168 hours after trabectedin infusion in course 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 352-273-0558
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications of Results:

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00070109     History of Changes
Other Study ID Numbers: ADVL0221
NCI-2009-00357 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000329999 ( Other Identifier: Clinical Trials.gov )
COG-ADVL0221 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2003
First Posted: October 7, 2003
Results First Submitted: December 9, 2013
Results First Posted: January 27, 2014
Last Update Posted: September 29, 2014