OsteosarcomaPhase 2NCT00520936

A Study of Pemetrexed in Children With Recurrent Cancer

A Phase 2 study testing pemetrexed in people with Osteosarcoma and Medulloblastoma, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages Up to 22 years
Conditions the study is for: Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's
What is being tested?: pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 22 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

Conditions: Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable)
Being tested: pemetrexed
Medical subject headings: Osteosarcoma, Medulloblastoma, Sarcoma, Ewing, Neuroblastoma, Rhabdomyosarcoma, Ependymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pemetrexedDrug
Also called LY 231514, Alimta
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

Study groups in NCT00520936
Study group	Role	What they receive
Pemetrexed	Experimental	Not described Receives: Drug: pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Feb 2010

First posted27 Aug 2007 (estimated)
Study startSep 2007
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteosarcomaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00520936
Sponsor's protocol ID: 10294
Other IDs: H3E-MC-JMHW, ADVL0525
Status last verified: Feb 2011
First submitted: 24 Aug 2007
Last updated: 25 Feb 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteosarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Pemetrexed in Children With Recurrent Malignancies
ClinicalTrials.gov ID: NCT00520936
Acronym / sponsor ID: 10294
Conditions: Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease), Neuroblastoma (Metaiodobenzylguanidine, Positive Evaluable)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Children's Oncology Group
Study start: Sep 2007
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 27 Aug 2007 (estimated)
Results: Posted 23 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pemetrexed	Experimental	Drug: pemetrexed

Who may qualify

Ages: Up to 22 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pemetrexedAlso: LY 231514, Alimta1910 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	Drug	Pemetrexed

Primary outcome

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.

2 secondary outcomes

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)
Pharmacogenomics - Measure the Response of Genes Related to Toxicity
Time frame: baseline

Results and safety

Results posted to the registry on 23 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Osteosarcoma	10	10
Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors	11	7
Rhabdomyosarcoma	9	7
Neuroblastoma (Measureable Disease)	5	5
Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)	6	5
Ependymoma	10	10
Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor	11	7
Non-Brainstem High-Grade Glioma	10	9

Primary outcome: Percentage of Participants With Overall Tumor Response (Response Rate)

Time frame: baseline to measured progressive disease (up to 1 year). Number. Unit: Percentage of Participants

Measure	Osteosarcoma n = 10	Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors n = 11	Rhabdomyosarcoma n = 9	Neuroblastoma (Measureable Disease) n = 5	Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) n = 6	Ependymoma n = 10	Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor n = 11	Non-Brainstem High-Grade Glioma n = 10
Value	0	0	0	0	0	0	0	0

Population analysed: All treated participants.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed	21 of 72 (29.2%)	10 of 72 (13.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Osteosarcoma

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Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
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RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
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RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed in people with Osteosarcoma and Medulloblastoma, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Overall Tumor Response (Response Rate) (time frame: baseline to measured progressive disease (up to 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00520936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2011.