A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
N/A
22 Years
Both
Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable), Rhabdomyosarcoma, Ependymoma, Non-brainstem High-grade Glioma
Trial Information
A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Overall Tumor Response (Response Rate)
Outcome 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.
Outcome Time Frame:
baseline to measured progressive disease (up to 1 year)
Safety Issue:
No
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
10294
NCT ID:
NCT00520936
Start Date:
September 2007
Completion Date:
February 2010
Related Keywords:
- Osteosarcoma
- Medulloblastoma
- Sarcoma, Ewing's
- Neuroblastoma (Measurable Disease)
- Neuroblastoma (Metaiodobenzylguanidine
- Positive Evaluable)
- Rhabdomyosarcoma
- Ependymoma
- Non-brainstem High-grade Glioma
- Ependymoma
- Glioma
- Medulloblastoma
- Neuroblastoma
- Osteosarcoma
- Rhabdomyosarcoma
- Sarcoma, Ewing's
- Sarcoma
Name | Location |
|---|---|
| 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. | Greenbrae, California 94904 |
