A Study of Pemetrexed in Children With Recurrent Cancer

Phase 2CompletedNCT00520936

Eli Lilly and Company72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease)Neuroblastoma (Metaiodobenzylguanidine

Eligibility

Sex: ALLMax age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Outcomes

Primary Outcomes

Percentage of Participants With Overall Tumor Response (Response Rate)

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.

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

Secondary Outcomes

Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug

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.

Time frame: every cycle (up to 2 years and 7 months)

Pharmacogenomics - Measure the Response of Genes Related to Toxicity

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.

Time frame: baseline