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: November 1, 2016

Last verified: November 2016

History of Changes

Results First Received: March 19, 2015

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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
Overall Participants Analyzed [Units: Participants]	11	12	11	12	46

Age [Units: Participants] Count of Participants
<=18 years	7 63.6%	8 66.7%	9 81.8%	7 58.3%	31 67.4%
Between 18 and 65 years	4 36.4%	4 33.3%	2 18.2%	5 41.7%	15 32.6%
>=65 years	0 0.0%	0 0.0%	0 0.0%	0 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] Count of Participants
Female	1 9.1%	6 50.0%	8 72.7%	5 41.7%	20 43.5%
Male	10 90.9%	6 50.0%	3 27.3%	7 58.3%	26 56.5%

Ethnicity (NIH/OMB) [Units: Participants] Count of Participants
Hispanic or Latino	1 9.1%	0 0.0%	3 27.3%	0 0.0%	4 8.7%
Not Hispanic or Latino	10 90.9%	12 100.0%	8 72.7%	11 91.7%	41 89.1%
Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	1 8.3%	1 2.2%

Race (NIH/OMB) [Units: Participants] Count of Participants
American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Asian	1 9.1%	1 8.3%	0 0.0%	2 16.7%	4 8.7%
Native Hawaiian or Other Pacific Islander	0 0.0%	2 16.7%	0 0.0%	0 0.0%	2 4.3%
Black or African American	2 18.2%	0 0.0%	0 0.0%	1 8.3%	3 6.5%
White	7 63.6%	8 66.7%	9 81.8%	7 58.3%	31 67.4%
More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Unknown or Not Reported	1 9.1%	1 8.3%	2 18.2%	2 16.7%	6 13.0%

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) ]

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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.

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.

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.

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.

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	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:	NCT01614795 History of Changes
Other Study ID Numbers:	NCI-2012-01971 NCI-2012-01971 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ADVL1221 ( Other Identifier: Children's Oncology Group ) CDR0000734871 ( Other Identifier: clinical trials.gov ) ADVL1221 ( Other Identifier: Children's Oncology Group ) ADVL1221 ( Other Identifier: CTEP ) U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received:	June 6, 2012
Results First Received:	March 19, 2015
Last Updated:	November 1, 2016

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