A Study of Pemetrexed in Children With Recurrent Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Rhabdomyosarcoma Ependymoma Non-brainstem High-grade Glioma |
Drug: pemetrexed |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pemetrexed in Children With Recurrent Malignancies |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Percentage of Participants With Overall Tumor Response (Response Rate) [ Time Frame: baseline to measured progressive disease (up to 1 year) ] [ Designated as safety issue: No ]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 [ Time Frame: every cycle (up to 2 years and 7 months) ] [ Designated as safety issue: Yes ]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 [ Time Frame: baseline ] [ Designated as safety issue: No ]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.
| Enrollment: | 72 |
| Study Start Date: | September 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pemetrexed |
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
Other Names:
|
Eligibility| Ages Eligible for Study: | up to 22 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520936
Locations
| United States, California | |
| 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, United States, 91066 | |
Sponsors and Collaborators
Eli Lilly and Company
Children's Oncology Group
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
Additional Information:
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 |
Additional relevant MeSH terms:
|
Ependymoma Glioma Medulloblastoma Neuroblastoma Osteosarcoma Rhabdomyosarcoma Sarcoma, Ewing's Sarcoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Myosarcoma Neoplasms, Muscle Tissue Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 16, 2013