Trial record 1 of 1 for:    COG ADVL1121
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Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01502410
First received: December 29, 2011
Last updated: May 14, 2015
Last verified: May 2015
Results First Received: April 14, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Childhood Hepatocellular Carcinoma
Papillary Thyroid Cancer
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Liver Cancer
Recurrent Childhood Rhabdomyosarcoma
Recurrent Thyroid Cancer
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Interventions: Drug: sorafenib tosylate
Other: pharmacological study
Other: laboratory biomarker analysis

  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
No text entered.

Reporting Groups
  Description
Group 1 Relapsed/Refractory Rhabdomyosarcoma

Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Group 2 Relapsed/Refractory Wilms Tumor

Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Group 3 Relapsed/Refractory Hepatocellular Carcinoma

Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Group 4 Papillary Thyroid Carcinoma

Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies


Participant Flow:   Overall Study
    Group 1 Relapsed/Refractory Rhabdomyosarcoma     Group 2 Relapsed/Refractory Wilms Tumor     Group 3 Relapsed/Refractory Hepatocellular Carcinoma     Group 4 Papillary Thyroid Carcinoma  
STARTED     10     10     0     0  
COMPLETED     0     0     0     0  
NOT COMPLETED     10     10     0     0  
Adverse Event                 1                 2                 0                 0  
Lack of Efficacy                 7                 7                 0                 0  
Physician Decision                 0                 1                 0                 0  
Withdrawal by Subject                 2                 0                 0                 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.
No text entered.

Reporting Groups
  Description
Group 1 Relapsed/Refractory Rhabdomyosarcoma

Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Group 2 Relapsed/Refractory Wilms Tumor

Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Group 3 Relapsed/Refractory Hepatocellular Carcinoma

Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Group 4 Papillary Thyroid Carcinoma

Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28

pharmacological study: Optional correlative studies

laboratory biomarker analysis: Optional correlative studies

Total Total of all reporting groups

Baseline Measures
    Group 1 Relapsed/Refractory Rhabdomyosarcoma     Group 2 Relapsed/Refractory Wilms Tumor     Group 3 Relapsed/Refractory Hepatocellular Carcinoma     Group 4 Papillary Thyroid Carcinoma     Total  
Number of Participants  
[units: participants]
  10     10     0     0     20  
Age  
[units: participants]
         
<=18 years     7     10             17  
Between 18 and 65 years     3     0             3  
>=65 years     0     0             0  
Age  
[units: years]
Median (Full Range)
  12   (5 to 21)     10.5   (7 to 18)                 11   (5 to 21)  
Gender  
[units: participants]
         
Female     4     5             9  
Male     6     5             11  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     0     2             2  
Not Hispanic or Latino     10     8             18  
Unknown or Not Reported     0     0             0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0             0  
Asian     0     1             1  
Native Hawaiian or Other Pacific Islander     0     0             0  
Black or African American     3     0             3  
White     7     7             14  
More than one race     0     0             0  
Unknown or Not Reported     0     2             2  
Region of Enrollment  
[units: participants]
         
United States     9     10             19  
Canada     1     0             1  



  Outcome Measures

1.  Primary:   Objective Response by RECIST Criteria v 1.1   [ Time Frame: 6 cycles (168 days) ]

2.  Secondary:   Progression-free Survival According to RECIST Version 1.1   [ Time Frame: From date of enrollment to the date of disease progression, date of death, date of removal of all tumor by surgery or last patient contact, whichever occurs first, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Pharmacokinetic (PK) Parameters of Sorafenib Tosylate   [ Time Frame: At baseline, up to 12 hours and on day 15 of course 1, and prior to odd courses ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in VEGF and VEGFR-2   [ Time Frame: From baseline to day 15 of course 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Presence of BRAF Mutation or RET/PTC Rearrangement   [ Time Frame: At baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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: 626-241-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01502410     History of Changes
Other Study ID Numbers: NCI-2012-00106, NCI-2012-00106, COG-ADVL1121, CDR0000721611, ADVL1121, ADVL1121, U10CA098543
Study First Received: December 29, 2011
Results First Received: April 14, 2015
Last Updated: May 14, 2015
Health Authority: United States: Food and Drug Administration