Back to resultsA Study of Pemetrexed in Children With Recurrent Cancer
Primary Purpose
Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance 0,1,2
- Adequate renal, liver and bone marrow function
- Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Exclusion Criteria:
- Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta)
- Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment
- Patients with uncontrolled infection
- Patients who have received pemetrexed previously
- Patients with pleural effusions or ascites
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemetrexed
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Overall Tumor Response (Response Rate)
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.
Secondary Outcome Measures
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.
Pharmacogenomics - Measure the Response of Genes Related to Toxicity
The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.
Full Information
NCT ID
NCT00520936
First Posted
August 24, 2007
Last Updated
February 23, 2011
Sponsor
Eli Lilly and Company
Collaborators
Children's Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00520936
Brief Title
A Study of Pemetrexed in Children With Recurrent Cancer
Official Title
A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Children's Oncology Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable), Rhabdomyosarcoma, Ependymoma, Non-brainstem High-grade Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
LY 231514, Alimta
Intervention Description
1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles
Primary Outcome Measure Information:
Title
Percentage of Participants With Overall Tumor Response (Response Rate)
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)
Secondary Outcome Measure Information:
Title
Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
Description
AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.
Time Frame
every cycle (up to 2 years and 7 months)
Title
Pharmacogenomics - Measure the Response of Genes Related to Toxicity
Description
The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.
Time Frame
baseline
10. Eligibility
Sex
All
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance 0,1,2
Adequate renal, liver and bone marrow function
Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Exclusion Criteria:
Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta)
Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment
Patients with uncontrolled infection
Patients who have received pemetrexed previously
Patients with pleural effusions or ascites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Arcadia
State/Province
California
ZIP/Postal Code
91066
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Pemetrexed in Children With Recurrent Cancer
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