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Completed

NCT Number: NCT00520936

A Study of Pemetrexed in Children With Recurrent Cancer

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.

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Key information

Conditions

Osteosarcoma Ependymoma Glioma Medulloblastoma Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Muscle Tissue Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroblastoma Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Non-brainstem High-grade Glioma Positive Evaluable) Rhabdomyosarcoma Sarcoma Sarcoma, Ewing Sarcoma, Ewing's

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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.

Arcadia, California, 91066, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

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: LY 231514, Alimta

Primary outcomes

  1. Percentage of Participants With Overall Tumor Response (Response Rate)

    Time frame: baseline to measured progressive disease (up to 1 year)

    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 outcomes

  1. 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)

    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.

  2. Pharmacogenomics - Measure the Response of Genes Related to Toxicity

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Children's Oncology Group

Registry information

Official study title

A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2007
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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