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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055314
First Posted: January 25, 2010
Last Update Posted: August 29, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: August 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Metastatic Childhood Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Untreated Childhood Rhabdomyosarcoma
Interventions: Biological: Cixutumumab
Drug: Cyclophosphamide
Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Ifosfamide
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Temozolomide
Drug: Vincristine Sulfate Liposome

  Participant Flow
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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
The number of participants started is 175. Eight patients were declared ineligible by the study chair, and one patient didn’t receive treatment.

Reporting Groups
  Description
IMC-A12 IMC-A12 + Multi-agent intensive chemotherapy regimen.
Temozolomide Add temozolomide to vincristine/irinotecan cycles.

Participant Flow:   Overall Study
    IMC-A12   Temozolomide
STARTED   100   75 
COMPLETED   55   37 
NOT COMPLETED   45   38 
Adverse Event                7                4 
Death                2                1 
Lack of Efficacy                11                19 
Physician Decision                10                5 
Withdrawal by Subject                1                0 
Ineligible                3                5 
Refusal of further protocol therapy                10                4 
No treatment                1                0 



  Baseline Characteristics
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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.
175 patients were enrolled on the study.

Reporting Groups
  Description
IMC-A12 IMC-A12 + Multi-agent intensive chemotherapy regimen.
Temozolomide Add temozolomide to vincristine/irinotecan cycles.
Total Total of all reporting groups

Baseline Measures
   IMC-A12   Temozolomide   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   75   175 
Age 
[Units: Months]
Mean (Standard Deviation)
 161.93  (67.36)   152.04  (79.20)   157.69  (72.62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      53  53.0%      30  40.0%      83  47.4% 
Male      47  47.0%      45  60.0%      92  52.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      17  17.0%      18  24.0%      35  20.0% 
Not Hispanic or Latino      77  77.0%      55  73.3%      132  75.4% 
Unknown or Not Reported      6   6.0%      2   2.7%      8   4.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      3   3.0%      0   0.0%      3   1.7% 
Native Hawaiian or Other Pacific Islander      1   1.0%      1   1.3%      2   1.1% 
Black or African American      12  12.0%      10  13.3%      22  12.6% 
White      74  74.0%      53  70.7%      127  72.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      10  10.0%      11  14.7%      21  12.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment   [ Time Frame: From start to week 26 of therapy ]

2.  Primary:   Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment   [ Time Frame: From start to week 26 of therapy ]

3.  Primary:   Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Up to 54 weeks ]

4.  Primary:   Event-Free Survival   [ Time Frame: 3 years ]

5.  Secondary:   Response Rate (CR + PR)   [ Time Frame: From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01055314     History of Changes
Other Study ID Numbers: NCI-2011-02005
NCI-2011-02005 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST08P1
ARST08P1 ( Other Identifier: Children's Oncology Group )
ARST08P1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: January 22, 2010
First Posted: January 25, 2010
Results First Submitted: August 18, 2016
Results First Posted: July 28, 2017
Last Update Posted: August 29, 2017