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A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

Phase 2
22 Years
Not Enrolling
Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable), Rhabdomyosarcoma, Ependymoma, Non-brainstem High-grade Glioma

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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

- Patients with uncontrolled infection

- Patients who have received pemetrexed previously

- Patients with pleural effusions or ascites

Type of Study:


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:


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


United States: Food and Drug Administration

Study ID:




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



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