A Study of Pemetrexed in Children With Recurrent Cancer

This study has been completed.

Sponsor:

Collaborator:

Children's Oncology Group

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00520936

First received: August 24, 2007

Last updated: February 23, 2011

Last verified: February 2011

History of Changes

Results First Received: February 1, 2011

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:	Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Rhabdomyosarcoma Ependymoma Non-brainstem High-grade Glioma
Intervention:	Drug: pemetrexed

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
No text entered.

Reporting Groups

	Description
Osteosarcoma	Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Rhabdomyosarcoma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Measureable Disease)	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Ependymoma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Non-Brainstem High-Grade Glioma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

Participant Flow: Overall Study

	Osteosarcoma	Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	Rhabdomyosarcoma	Neuroblastoma (Measureable Disease)	Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	Ependymoma	Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	Non-Brainstem High-Grade Glioma
STARTED	10 ^[1]	11	9	5	6	10	11	10
COMPLETED	10 ^[2]	7	7	5	5	10	7	9
NOT COMPLETED	0	4	2	0	1	0	4	1
Physician Decision	0	2	1	0	0	0	0	0
Withdrawal by Subject	0	0	0	0	0	0	0	1
Toxicity Requiring Removal from Study	0	1	0	0	0	0	2	0
Death	0	0	0	0	0	0	1	0
Protocol Violation	0	1	1	0	1	0	1	0

[1]	75 participants entered the study and 72 were enrolled and received study drug.
[2]	Study completion defined as treated until disease progression. Completed=progressive disease.

Baseline Characteristics

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Reporting Groups

	Description
Osteosarcoma	Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Rhabdomyosarcoma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Measureable Disease)	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Ependymoma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Non-Brainstem High-Grade Glioma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Total	Total of all reporting groups

Baseline Measures

	Osteosarcoma	Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	Rhabdomyosarcoma	Neuroblastoma (Measureable Disease)	Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	Ependymoma	Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	Non-Brainstem High-Grade Glioma	Total
Number of Participants [units: participants]	10	11	9	5	6	10	11	10	72
Age [units: years] Mean ± Standard Deviation	14.94 ± 4.28	18.24 ± 3.35	8.74 ± 4.96	6.23 ± 2.98	9.62 ± 5.38	8.42 ± 4.59	12.00 ± 7.13	12.75 ± 5.15	11.96 ± 5.97
Gender [units: participants]
Female	4	8	6	1	1	3	4	5	32
Male	6	3	3	4	5	7	7	5	40
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaska Native	0	0	2	0	0	0	0	0	2
Asian	0	1	0	0	0	0	0	1	2
Black or African American	4	0	0	2	1	1	3	3	14
White	4	8	7	2	4	9	8	6	48
Other	1	1	0	1	0	0	0	0	3
Unknown	1	1	0	0	1	0	0	0	3
Region of Enrollment [units: participants]
United States	7	7	8	5	5	9	10	10	61
Canada	3	4	1	0	1	1	1	0	11
Karnofsky Performance Score ^[1] [units: Participants]
100	0	2	0	0	0	1	0	0	3
90	3	3	0	0	1	0	1	1	9
80	0	1	0	0	0	0	0	1	2
70	0	1	0	0	0	0	1	0	2
50	1	0	0	0	0	0	1	0	2
Missing	6	4	9	5	5	9	8	8	54
Lansky Play Score ^[2] [units: Participants]
100	1	1	3	4	2	2	2	3	18
90	1	3	3	1	1	2	3	4	18
80	2	0	2	0	2	3	2	0	11
70	0	0	0	0	0	1	0	1	2
60	1	0	1	0	0	1	1	0	4
50	1	0	0	0	0	0	0	0	1
Missing	4	7	0	0	1	1	3	2	18

[1]	Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. 100 - Normal no complaints; no evidence of disease 90 - Normal activity; minor signs of disease 80 - Activity with effort; some signs of disease 70 - Unable to carry on normal activity <=60 Needs increasing assistance up to Death (0)
[2]	100=fully active, normal. 90=minor restrictions in physically strenuous activity. 80=active, but tires more quickly. 70=both greater restriction of and less time spent in play activity. 60=up and around, but minimal active play; keeps busy with quieter activities. 50=gets dressed, but lies around much of the day; no active play, able to participate in all quiet play activities. 40=mostly in bed; participates in quiet activities. 30=in bed; needs assistance even for quiet play. 20=often sleeping; play entirely limited to very passive activities. 10=No play; does not get out of bed.

[1]

Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses.

100 - Normal no complaints; no evidence of disease 90 - Normal activity; minor signs of disease 80 - Activity with effort; some signs of disease 70 - Unable to carry on normal activity <=60 Needs increasing assistance up to Death (0)

[2]

100=fully active, normal. 90=minor restrictions in physically strenuous activity. 80=active, but tires more quickly. 70=both greater restriction of and less time spent in play activity. 60=up and around, but minimal active play; keeps busy with quieter activities. 50=gets dressed, but lies around much of the day; no active play, able to participate in all quiet play activities. 40=mostly in bed; participates in quiet activities. 30=in bed; needs assistance even for quiet play. 20=often sleeping; play entirely limited to very passive activities. 10=No play; does not get out of bed.

Outcome Measures

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1. Primary:

Percentage of Participants With Overall Tumor Response (Response Rate) [ Time Frame: baseline to measured progressive disease (up to 1 year) ]

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Measure Type	Primary
Measure Title	Percentage of Participants With Overall Tumor Response (Response Rate)
Measure Description	Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100.
Time Frame	baseline to measured progressive disease (up to 1 year)
Safety Issue	No

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.
All treated participants.

Reporting Groups

	Description
Osteosarcoma	Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Rhabdomyosarcoma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Measureable Disease)	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Ependymoma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
Non-Brainstem High-Grade Glioma	Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

Measured Values

	Osteosarcoma	Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	Rhabdomyosarcoma	Neuroblastoma (Measureable Disease)	Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	Ependymoma	Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	Non-Brainstem High-Grade Glioma
Number of Participants Analyzed [units: participants]	10	11	9	5	6	10	11	10
Percentage of Participants With Overall Tumor Response (Response Rate) [units: Percentage of Participants]	0	0	0	0	0	0	0	0

No statistical analysis provided for Percentage of Participants With Overall Tumor Response (Response Rate)

2. Secondary:

Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug [ Time Frame: every cycle (up to 2 years and 7 months) ]

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3. Secondary:

Pharmacogenomics - Measure the Response of Genes Related to Toxicity [ Time Frame: baseline ]

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Serious Adverse Events

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Other Adverse Events

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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.

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.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00520936 History of Changes
Obsolete Identifiers:	NCT00459147
Other Study ID Numbers:	10294, H3E-MC-JMHW, ADVL0525
Study First Received:	August 24, 2007
Results First Received:	February 1, 2011
Last Updated:	February 23, 2011
Health Authority:	United States: Food and Drug Administration

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