A Study of Pemetrexed in Children With Recurrent Cancer

Osteosarcoma Clinical Trial

Official title:

A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520936
• Other study ID #: 10294
• Secondary ID: H3E-MC-JMHWADVL0
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2007
• Last updated: February 23, 2011
• Start date: September 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00459147
• NCT00739427

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 22 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• pemetrexed
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

Locations

Country	Name	City	State
United States	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.	Arcadia	California

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Children's Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to measured progressive disease (up to 1 year)	No
Secondary	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.	every cycle (up to 2 years and 7 months)	Yes
Secondary	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.	baseline	No

External Links

•   Lilly Clinical Trial Registry