Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00831844
First received: January 28, 2009
Last updated: March 18, 2015
Last verified: March 2015
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Rhabdomyosarcoma
Adult Synovial Sarcoma
Childhood Hepatoblastoma
Childhood Synovial Sarcoma
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Adrenocortical Carcinoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Childhood Liver Cancer
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive
Neuroectodermal Tumor
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Recurrent Retinoblastoma
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Interventions: Biological: cixutumumab
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 patients were enrolled in Group 10, recurrent or refractory retinoblastoma.

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 - Recurrent or Refractory Hepatoblastoma

Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 2 - Recurrent or Refractory Synovial Sarcoma

Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 3 - Recurrent or Refractory Rhabdomyosarcoma

Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 4-Recurrent or Refractory Adrenocortical Carcinoma

Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease

Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 7-Neuroblastoma With Measurable Disease

Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 8 - Recurrent Osteosarcoma

Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 9 - Recurrent or Refractory Wilms Tumor

Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 10 - Recurrent or Refractory Retinoblastoma

Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Group 1 - Recurrent or Refractory Hepatoblastoma     Group 2 - Recurrent or Refractory Synovial Sarcoma     Group 3 - Recurrent or Refractory Rhabdomyosarcoma     Grp 4-Recurrent or Refractory Adrenocortical Carcinoma     Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor     Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease     Grp 7-Neuroblastoma With Measurable Disease     Group 8 - Recurrent Osteosarcoma     Group 9 - Recurrent or Refractory Wilms Tumor     Group 10 - Recurrent or Refractory Retinoblastoma  
STARTED     10     12     21     10     14     20     10     10     9     0  
COMPLETED     0     0     1     0     0     1     0     0     0     0  
NOT COMPLETED     10     12     20     10     14     19     10     10     9     0  
Adverse Event                 2                 0                 0                 0                 1                 1                 2                 0                 0                 0  
Death                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 8                 10                 15                 8                 11                 17                 8                 9                 7                 0  
Physician Decision                 0                 1                 3                 1                 1                 1                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 0                 0                 1                 1                 0  
Ineligible                 0                 1                 1                 0                 1                 0                 0                 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.
Group 10, Recurrent or Refractory Retinoblastoma no patients were enrolled.

Reporting Groups
  Description
Group 1 - Recurrent or Refractory Hepatoblastoma

Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 2 - Recurrent or Refractory Synovial Sarcoma

Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 3 - Recurrent or Refractory Rhabdomyosarcoma

Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 4-Recurrent or Refractory Adrenocortical Carcinoma

Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease

Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 7-Neuroblastoma With Measurable Disease

Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 8 - Recurrent Osteosarcoma

Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 9 - Recurrent or Refractory Wilms Tumor

Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 10 - Recurrent or Refractory Retinoblastoma

Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Group 1 - Recurrent or Refractory Hepatoblastoma     Group 2 - Recurrent or Refractory Synovial Sarcoma     Group 3 - Recurrent or Refractory Rhabdomyosarcoma     Grp 4-Recurrent or Refractory Adrenocortical Carcinoma     Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor     Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease     Grp 7-Neuroblastoma With Measurable Disease     Group 8 - Recurrent Osteosarcoma     Group 9 - Recurrent or Refractory Wilms Tumor     Group 10 - Recurrent or Refractory Retinoblastoma     Total  
Number of Participants  
[units: participants]
  10     12     21     10     14     20     10     10     9     0     116  
Age  
[units: participants]
                     
<=18 years     10     8     16     8     9     18     7     8     9         93  
Between 18 and 65 years     0     4     5     2     5     2     3     2     0         23  
>=65 years     0     0     0     0     0     0     0     0     0         0  
Age  
[units: years]
Median ( Full Range )
  3  
  ( 2 to 7 )  
  17.5  
  ( 12 to 26 )  
  14  
  ( 3 to 22 )  
  14  
  ( 10 to 29 )  
  17  
  ( 8 to 28 )  
  10.5  
  ( 2 to 30 )  
  14.5  
  ( 4 to 26 )  
  14.5  
  ( 3 to 24 )  
  7  
  ( 4 to 14 )  
   
   
  13  
  ( 2 to 30 )  
Gender  
[units: participants]
                     
Female     3     6     6     6     6     8     9     3     8         55  
Male     7     6     15     4     8     12     1     7     1         61  
Ethnicity (NIH/OMB)  
[units: participants]
                     
Hispanic or Latino     1     4     3     2     0     2     1     1     1         15  
Not Hispanic or Latino     7     8     17     8     14     18     8     9     7         96  
Unknown or Not Reported     2     0     1     0     0     0     1     0     1         5  
Race (NIH/OMB)  
[units: participants]
                     
American Indian or Alaska Native     0     0     0     0     0     0     0     0     0         0  
Asian     1     1     1     0     1     0     1     0     0         5  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0     0     0         0  
Black or African American     2     0     4     1     0     3     0     3     2         15  
White     4     9     13     8     12     16     6     6     6         80  
More than one race     0     0     0     0     0     0     0     0     0         0  
Unknown or Not Reported     3     2     3     1     1     1     3     1     1         16  
Region of Enrollment  
[units: participants]
                     
United States     10     11     18     9     14     19     9     10     8         108  
Canada     0     1     0     1     0     0     0     0     0         2  
Australia     0     0     3     0     0     1     1     0     1         6  



  Outcome Measures

1.  Primary:   Disease Response   [ Time Frame: First six treatment cycles - 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: NCT00831844     History of Changes
Other Study ID Numbers: NCI-2009-01170, NCI-2009-01170, CDR0000633186, COG-ADVL0821, ADVL0821, ADVL0821, U10CA098543
Study First Received: January 28, 2009
Results First Received: March 18, 2015
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration