Trial record 1 of 1 for:    ADVL1221
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Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01614795
First received: June 6, 2012
Last updated: March 19, 2015
Last verified: February 2015
Results First Received: March 19, 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: Childhood Alveolar Soft-part Sarcoma
Childhood Angiosarcoma
Childhood Epithelioid Sarcoma
Childhood Fibrosarcoma
Childhood Gliosarcoma
Childhood Leiomyosarcoma
Childhood Liposarcoma
Childhood Neurofibrosarcoma
Childhood Synovial Sarcoma
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Osteosarcoma
Interventions: Biological: cixutumumab
Drug: temsirolimus
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 or Refractory Osteosarcoma

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Group 3 Relapsed or Refractory Rhabdomyosarcoma

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Group 1 Relapsed or Refractory Osteosarcoma     Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET     Group 3 Relapsed or Refractory Rhabdomyosarcoma     Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma  
STARTED     11     12     11     12  
COMPLETED     0     0     0     0  
NOT COMPLETED     11     12     11     12  
Adverse Event                 0                 0                 1                 1  
Lack of Efficacy                 10                 10                 9                 8  
Physician Decision                 1                 0                 1                 1  
Withdrawal by Subject                 0                 1                 0                 2  
Ineligible                 0                 1                 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 or Refractory Osteosarcoma

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Group 3 Relapsed or Refractory Rhabdomyosarcoma

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma

Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).

temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Group 1 Relapsed or Refractory Osteosarcoma     Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET     Group 3 Relapsed or Refractory Rhabdomyosarcoma     Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma     Total  
Number of Participants  
[units: participants]
  11     12     11     12     46  
Age  
[units: participants]
         
<=18 years     7     8     9     7     31  
Between 18 and 65 years     4     4     2     5     15  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Median ( Full Range )
  18  
  ( 7 to 25 )  
  17.5  
  ( 9 to 27 )  
  14  
  ( 1 to 23 )  
  17.5  
  ( 13 to 26 )  
  17  
  ( 1 to 27 )  
Gender  
[units: participants]
         
Female     1     6     8     5     20  
Male     10     6     3     7     26  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     1     0     3     0     4  
Not Hispanic or Latino     10     12     8     11     41  
Unknown or Not Reported     0     0     0     1     1  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     1     1     0     2     4  
Native Hawaiian or Other Pacific Islander     0     2     0     0     2  
Black or African American     2     0     0     1     3  
White     7     8     9     7     31  
More than one race     0     0     0     0     0  
Unknown or Not Reported     1     1     2     2     6  
Region of Enrollment  
[units: participants]
         
United States     11     11     11     12     45  
Canada     0     1     0     0     1  



  Outcome Measures

1.  Primary:   Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).   [ Time Frame: 6 cycles (168 days) ]

2.  Secondary:   Progression-free Survival   [ Time Frame: The date of enrollment until the end PFI date, calculated as 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:   Percentage of Patients Expressing IGF-1R, Insulin Receptor, ERK, RON, and mTOR   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Percentage of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Observed Incidence in Each Reporting Period by Type and Grade of Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0   [ Time Frame: 25 cycles (700 days) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01614795     History of Changes
Other Study ID Numbers: NCI-2012-01971, NCI-2012-01971, COG-ADVL1221, CDR0000734871, ADVL1221, ADVL1221, U10CA098543
Study First Received: June 6, 2012
Results First Received: March 19, 2015
Last Updated: March 19, 2015
Health Authority: United States: Food and Drug Administration