GliomaPhase 1NCT00532948

A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

A Phase 1 study testing capecitabine [Xeloda] in people with Glioma, run by Hoffmann-La Roche at 9 sites 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

Who is it for?: Ages 3 to 21 years
Conditions the study is for: Glioma
What is being tested?: capecitabine [Xeloda]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 9 sitesUnited States
Study dates: May 2007to Oct 2010
Phase: Phase 1
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 3 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

patients >=3 and <=21 years of age;
newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma;
Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;
adequate organ function.

Who cannot join

previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
uncontrolled infection;
known DPD deficiency.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Study site
Boston, Massachusetts, 02115-6084
Study site
Chicago, Illinois, 60614
Study site
Durham, North Carolina, 27710
Study site
Houston, Texas, 77030
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15261
Study site
San Francisco, California, 94143-0780
Study site
Seattle, Washington, 98105
Study site
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas

This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.

Conditions: Glioma
Being tested: capecitabine [Xeloda]
Medical subject headings: Glioma

What participants receive

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

capecitabine [Xeloda]Drug
500mg/m2 po bid (starting dose)

Study groups in NCT00532948
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: capecitabine [Xeloda]

What is being measured

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

Maximum Tolerated Dose (MTD) of Capecitabine.
The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.
Measured: Upto 11 weeks.
Dose Limiting Toxicities (DLTs)
DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs).
Measured: Upto 11 weeks
Number of Participants With Adverse Events (AE)
An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category.
Measured: Up to 06 years
Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters
For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils.
Measured: Up to 06 years
Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters
For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose.
Measured: Up to 06 years

Secondary outcomes (4)

Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])
The maximum observed plasma concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).
Measured: Day 1 and Day 14
Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)
Tmax is the corresponding time at which Cmax occurs of capecitabine and its metabolites.Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).
Measured: Day 1 and Day 14
The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)
AUC last concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).
Measured: Day 1 and Day 14
Anti Tumor Activity
Tumor response refers to the best response prior to failure (disease progression, death or second malignancy).
Measured: Up to 6 years

Timeline

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

May 2007Oct 2010

First posted21 Sep 2007 (estimated)
Study startMay 2007
Primary completionOct 2010
Study completionOct 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 GliomaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00532948
Sponsor's protocol ID: NO18517
Status last verified: Oct 2016
First submitted: 20 Sep 2007
Last updated: 7 Dec 2016
Results posted: Yes, on ClinicalTrials.gov

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
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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 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas
ClinicalTrials.gov ID: NCT00532948
Acronym / sponsor ID: NO18517
Conditions: Glioma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 21 Sep 2007 (estimated)
Results: Posted 15 Mar 2016

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
1	Experimental	Drug: capecitabine [Xeloda]

Who may qualify

Ages: 3 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

patients >=3 and <=21 years of age;
newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma;
Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;
adequate organ function.

Key exclusion criteria (3 listed)

previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
uncontrolled infection;
known DPD deficiency.

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
capecitabine [Xeloda]500mg/m2 po bid (starting dose)	Drug	1

Primary outcome

Maximum Tolerated Dose (MTD) of Capecitabine.
Time frame: Upto 11 weeks.
The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.
Dose Limiting Toxicities (DLTs)
Time frame: Upto 11 weeks
DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs).
Number of Participants With Adverse Events (AE)
Time frame: Up to 06 years
An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category.
Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters
Time frame: Up to 06 years
For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils.
Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters
Time frame: Up to 06 years
For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose.

4 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])
Time frame: Day 1 and Day 14
Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)
Time frame: Day 1 and Day 14
The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)
Time frame: Day 1 and Day 14
Anti Tumor Activity
Time frame: Up to 6 years

Results and safety

Results posted to the registry on 15 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Capecitabine 500 mg/m^2	4	0
Capecitabine 650 mg/m^2	14	9
Capecitabine 850 mg/m^2	6	2

Primary outcome: Maximum Tolerated Dose (MTD) of Capecitabine.

Time frame: Upto 11 weeks.. Number. Unit: milligrams

Measure	Capecitabine (Overall) n = 22
Value	650

Population analysed: The safety population consisted of all eligible patients who received at least one dose of capecitabine.

Primary outcome: Dose Limiting Toxicities (DLTs)

Time frame: Upto 11 weeks. Number. Unit: Participants

Measure	Capecitabine 500 mg/m^2 n = 4	Capecitabine 650 mg/m^2 n = 12	Capecitabine 850 mg/m^2 n = 6
Value	0	3	3

Population analysed: The safety population consisted of all eligible patients who received at least one dose of capecitabine.

Primary outcome: Number of Participants With Adverse Events (AE)

Time frame: Up to 06 years. Number. Unit: Participants

Measure	Capecitabine 500 mg/m^2 n = 4	Capecitabine 650 mg/m^2 n = 12	Capecitabine 850 mg/m^2 n = 6
Value	3	12	6

Population analysed: The safety population consisted of all eligible patients who received at least one dose of capecitabine.

Primary outcome: Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters

Time frame: Up to 06 years. Number. Unit: Participants

Measure	Capecitabine 500 mg/m^2 n = 4	Capecitabine 650 mg/m^2 n = 12	Capecitabine 850 mg/m^2 n = 6
Haematocrit, normal to low, n=3,1,5	2	1	4
Haematocrit, normal to high, n=3,1,5	0	0	0
Hemoglobin, normal to low, n=4,2,6	0	0	2
Hemoglobin, normal to high, n=4,2,6	0	0	0
White blood cell, normal to low, n=3,1,5	0	0	0
White blood cell, normal to high, n=3,1,5	1	1	1
Platelets, normal to low, n=4,2,6	0	1	0
Platelets, normal to high, n=4,2,6	0	0	1

Population analysed: The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Capecitabine 500 mg/m^2	2 of 4 (50%)	3 of 4 (75%)	Not reported
Capecitabine 650 mg/m^2	1 of 12 (8.3%)	12 of 12 (100%)	Not reported
Capecitabine 850 mg/m^2	3 of 6 (50%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Clinical Trials study chair

Hoffmann-La Roche

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing capecitabine [Xeloda] in people with Glioma, run by Hoffmann-La Roche at 9 sites 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 4 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 15 Mar 2016). 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?

Maximum Tolerated Dose (MTD) of Capecitabine. (time frame: Upto 11 weeks.). The study lists 5 primary outcomes in all. 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 NCT00532948.

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 7 Dec 2016.