GliomaPhase 2NCT00404495

Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

A Phase 2 study testing Irinotecan and Temozolomide in people with Glioma and Medulloblastoma, run by Pfizer at 29 sites in 8 countries.

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

This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma. Read more about this study

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Glioma, Medulloblastoma
What is being tested?: Irinotecan and Temozolomide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 29 sitesin 8 countries
Study dates: Apr 2007to Dec 2011
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 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)
Life expectancy ≥ 3 months

Who cannot join

Diagnosis of brainstem glioma
Concurrent administration of any other anti-tumor therapy
Pre-existing uncontrolled diarrhea

Trial locations and contacts

29 sites in 8 countries.

Country

City, postcode or hospital

29 sites in 8 countries

France7 sites

Pfizer Investigational Site
Angers, 49000
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Lille, 59020
Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Paris, 75005
Pfizer Investigational Site
Villejuif, 94805

Other trials in France

United Kingdom7 sites

Pfizer Investigational Site
Birmingham, B4 6NH
Pfizer Investigational Site
Leeds, LS9 7TF
Pfizer Investigational Site
Manchester, M27 4HA
Pfizer Investigational Site
Newcastle upon Tyne, NE1 4LP
Pfizer Investigational Site
Nottingham, NG7 2UH
Pfizer Investigational Site
Soouthampton, Hampshire, SO16 6YD
Pfizer Investigational Site
Sutton, SM2 5PT

Other trials in United Kingdom

Spain6 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
El Palmar, Murcia, 30120
Pfizer Investigational Site
Esplugues de Llobregat, Barcelona, 08950
Pfizer Investigational Site
Madrid, Madrid, 28009
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Valencia, Valencia, 46026

Other trials in Spain

Australia3 sites

Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Parkville, Victoria, 3052
Pfizer Investigational Site
Westmead, New South Wales, 2145

Other trials in Australia

Belgium2 sites

Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000

Other trials in Belgium

Denmark2 sites

Pfizer Investigational Site
Aarhus N, 8200
Pfizer Investigational Site
Koebenhavn OE, 2100

Other trials in Denmark

Italy1 site

Pfizer Investigational Site
Padova, 35100

Other trials in Italy

Poland1 site

Pfizer Investigational Site
Warsaw, 04-730

Other trials in Poland

About this study

Official title: Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.

Conditions: Glioma, Medulloblastoma
Being tested: Irinotecan, Temozolomide
Medical subject headings: Glioma, Medulloblastoma

What participants receive

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

IrinotecanDrug
Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
TemozolomideDrug
Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles

Study groups in NCT00404495
Study group	Role	What they receive
Temozolomide + Irinotecan	Experimental	Not described Receives: Drug: Irinotecan; Drug: Temozolomide

What is being measured

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

Percentage of Participants With Objective Response of Complete Response or Partial Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.
Measured: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)

Secondary outcomes (5)

Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study ≥4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment.
Measured: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Duration of Response
Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment.
Measured: Baseline to Date of Tumor Response (Up to 1 Year)
Time to Treatment Failure (TTF)
TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment.
Measured: Baseline to Date of Treatment Failure (Up to 1 Year)
Time to Tumor Progression (TTP)
TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment.
Measured: Baseline to Date of Progression (Up to 1 Year)
Overall Survival (OS)
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment.
Measured: Baseline to Date of Death (Up to 1 Year After Treatment)

Timeline

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

Apr 2007Dec 2011

First posted28 Nov 2006 (estimated)
Study startApr 2007
Primary completionJan 2011
Study completionDec 2011

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 GliomaStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00404495
Sponsor's protocol ID: A5961166
Status last verified: Apr 2012
First submitted: 27 Nov 2006
Last updated: 18 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

All Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.
ClinicalTrials.gov ID: NCT00404495
Acronym / sponsor ID: A5961166
Conditions: Glioma, Medulloblastoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Jan 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 28 Nov 2006 (estimated)
Results: Posted 17 Feb 2012

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Temozolomide + Irinotecan	Experimental	Drug: Irinotecan, Drug: Temozolomide

Who may qualify

Ages: 6 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)
Life expectancy ≥ 3 months

Key exclusion criteria (3 listed)

Diagnosis of brainstem glioma
Concurrent administration of any other anti-tumor therapy
Pre-existing uncontrolled diarrhea

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
IrinotecanIrinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles	Drug	Temozolomide + Irinotecan
TemozolomideTemozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles	Drug	Temozolomide + Irinotecan

Primary outcome

Percentage of Participants With Objective Response of Complete Response or Partial Response
Time frame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.

5 secondary outcomes

Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment
Time frame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)
Duration of Response
Time frame: Baseline to Date of Tumor Response (Up to 1 Year)
Time to Treatment Failure (TTF)
Time frame: Baseline to Date of Treatment Failure (Up to 1 Year)
Time to Tumor Progression (TTP)
Time frame: Baseline to Date of Progression (Up to 1 Year)
Overall Survival (OS)
Time frame: Baseline to Date of Death (Up to 1 Year After Treatment)

Results and safety

Results posted to the registry on 17 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Temozolomide + Irinotecan for Medulloblastoma	66	22
Temozolomide + Irinotecan for High-Grade Glioma	17	6

Primary outcome: Percentage of Participants With Objective Response of Complete Response or Partial Response

Time frame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Temozolomide + Irinotecan for Medulloblastoma n = 46	Temozolomide + Irinotecan for High-Grade Glioma n = 10
Value	32.6 (19.5 to 48.0)	0 (0 to 30.8)

Population analysed: Primary Evaluable Population: subset of evaluable population predetermined by 2-stage Optimum Simon design. Medulloblastoma cohort: n=consecutive evaluable participants up to 46 if 6 responses obtained in first 15 evaluable participants. Glioma cohort: n=consecutive evaluable participants up to 29 if 1 response in first 10 evaluable participants.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Temozolomide + Irinotecan for Medulloblastoma	31 of 66 (47%)	64 of 66 (97%)	Not reported
Temozolomide + Irinotecan for High-Grade Glioma	5 of 17 (29.4%)	17 of 17 (100%)	Not reported

Limitations and caveats (from the sponsor): This study had one treatment arm but two distinct cohorts with different diagnostics and treatment durations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

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.

Pfizer CT.gov Call Center study director

Pfizer

29 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan and Temozolomide in people with Glioma and Medulloblastoma, run by Pfizer at 29 sites in 8 countries.

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 3 inclusion and 3 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 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France, United Kingdom, Spain, Australia, Belgium and 3 more countries. 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 17 Feb 2012). 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 Objective Response of Complete Response or Partial Response (time frame: Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)). 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 NCT00404495.

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 18 Apr 2012.