A Study of Pemetrexed in Children With Recurrent Cancer

This study has been completed.
Sponsor:
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
  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:
  • LY 231514
  • Alimta

  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, NCT00739427
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 April 16, 2014