A Study of Pemetrexed in Children With Recurrent Cancer

NCT00520936 | Completed Phase 2 Results DMC

• 3 other identifiers: 10294H3E-MC-JMHWADVL0525
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteosarcoma; Medulloblastoma; Sarcoma, Ewing's; Neuroblastoma (Measurable Disease); Neuroblastoma (Metaiodobenzylguanidine; Positive Evaluable); Rhabdomyosarcoma; Ependymoma; Non-brainstem High-grade Glioma

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to measured progressive disease (up to 1 year)

Secondary Outcomes (2)

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

  every cycle (up to 2 years and 7 months)

• Pharmacogenomics - Measure the Response of Genes Related to Toxicity

  baseline

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Drug: pemetrexed

Interventions

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

Also known as: LY 231514, Alimta

Pemetrexed

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Children's Oncology Group: collaborator

Study Sites (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, 91066, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Osteosarcoma; Medulloblastoma; Sarcoma, Ewing; Neuroblastoma; Rhabdomyosarcoma; Ependymoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Myosarcoma; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 25, 2011
• Results First Posted: February 23, 2011

Record last verified: 2011-02

Locations

US (1)