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Brain and Central Nervous System TumorsPhase 1NCT00357253

Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma

A Phase 1 study testing capecitabine and radiation therapy in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 12 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

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Read more about this study

Who is it for?
Ages 3 to 21 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
capecitabine and radiation therapy
How many people
24 participants
Where
12 sitesUnited States
Study dates
Jan 2006to Mar 2010
Phase
Phase 1
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • One of the following newly diagnosed, nondisseminated brain tumors:
  • Intrinsic infiltrating brain stem glioma
  • Histopathologic diagnosis not required
  • Histopathologically confirmed high-grade glioma, meeting all of the following criteria:
  • Underwent prior definitive surgery ≤ 28 days ago with incompletely resected disease
  • Any of the following subtypes allowed:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Other high-grade glioma
  • No anaplastic oligodendroglioma

PATIENT CHARACTERISTICS:

  • Karnofsky performance scale (PS) 50-100% (if > 16 years of age) or Lansky PS 50-100% (if ≤ 16 years of age)
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusion independent)
  • Hemoglobin ≥ 8 g/dL (transfusion independent)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows:
  • No more than 0.8 mg/dL (for patients 5 years of age and under)
  • No more than 1 mg/dL (for patients 6-10 years of age)
  • No more than 1.2 mg/dL (for patients 11-15 years of age)
  • No more than 1.5 mg/dL (for patients over 15 years of age)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or other systemic disease
  • No known hypersensitivity to capecitabine or any of its components
  • No known dihydropyrimidine dehydrogenase (DPD) deficiency

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior dexamethasone and/or surgery allowed
  • No prior chemotherapy, radiotherapy, immunotherapy, or bone marrow transplantation
  • No other concurrent anticancer or experimental drug therapies or agents
  • No concurrent warfarin or sorivudine or its chemically related analogues (e.g., brivudine)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

    Houston, Texas, 77030-2399

  • Dan L. Duncan Cancer Center at Baylor College of Medicine

    Houston, Texas, 77030

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

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

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Giving capecitabine together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating young patients with newly diagnosed, nonmetastatic brain stem glioma or high-grade glioma.

Read the detailed description

OBJECTIVES:

Primary

  • Estimate the maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) administered concurrently with radiotherapy in young patients with newly diagnosed, nondisseminated intrinsic brain stem glioma or high-grade glioma.
  • Describe the dose-limiting toxicity in patients treated with this regimen.

Secondary

  • Describe the safety profile of this regimen.
  • Characterize the pharmacokinetics of capecitabine RDT in these patients.
  • Explore the exposure-response relationship for measures of safety and effectiveness using pharmacokinetic and pharmacodynamic models.
  • Describe the antitumor activity of this regimen observed in these patients.
  • Estimate distributions of progression-free survival and survival in patients treated with this regimen.
  • Characterize radiographic changes in tumor, using MRI, perfusion and diffusion MRI, and positron emission tomography (PET) scans, in patients treated with this regimen.

OUTLINE: This a multicenter, dose-escalation study of capecitabine rapidly disintegrating tablets (RDT).

Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Beginning within 24 hours of starting radiotherapy, patients also receive oral capecitabine RDT twice daily on days 1-21. Treatment with capecitabine RDT repeats every 21 days for 3 courses.

Cohorts of 3-6 patients receive escalating doses of capecitabine RDT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Beginning in week 12, patients receive capecitabine RDT at a fixed dose twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically during course 1 for pharmacokinetic correlative studies. Patients also undergo MRI, and rapid perfusion/diffusion MRI at baseline and periodically during study for radiographic correlative studies.

After completion of study treatment, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Being tested
capecitabine, radiation therapy
Keywords
untreated childhood brain stem glioma, childhood high-grade cerebral astrocytoma, untreated childhood cerebellar astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma

What participants receive

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

  • capecitabineDrug

    Also called Xeloda

    This is a dose escalation study. 375, 500, 650, or 850 mg/m2 capecitabine RDT is given orally daily in two divided doses approximately 12 hours apart beginning at the start of radiation therapy and continuing for 9 weeks. After a two week break, patients receive twice daily oral capecitabine, either 900 mg/m2 or 1250 mg/m2, approximately 12 hours apart for 14 days followed by a 7-day rest period for a total of 3 courses.

  • radiation therapyRadiation

    Participants receive local radiation once daily, 5 days/week for 9 weeks for a total dose of 5580 cGy.

What is being measured

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

  1. Maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy

    Measured: First 11 weeks of therapy

  2. Dose-limiting toxicity

    Measured: First 11 weeks of therapy

Secondary outcomes (4)

  1. Pharmacokinetics of capecitabine RDT measured periodically during course 1

    Measured: Day 1 and Day 14 of therapy

  2. Tumor response

    Brain imaging to assess tumor response to the treatment is performed at baseline, week 11, end of course 6, and then every 3 months for two years.

    Measured: From day 1 of treatment until off study

  3. Survival

    Measured: From initiation of treatment until death or off study

  4. Radiographic changes in gliomas as measured by MRI, magnetic resonance spectroscopy (MRS), perfusion and diffusion MRI

    Measured: Baseline, week 11, then every 3 months for 2 years or until off study

Timeline

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

  1. First posted27 Jul 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

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
NCT00357253
Sponsor's protocol ID
CDR0000484429
Other IDs
U01CA081457, PBTC-021
Status last verified
Jan 2013
First submitted
26 Jul 2006
Last updated
10 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing capecitabine and radiation therapy in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 12 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?

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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy (time frame: First 11 weeks of therapy). The study lists 2 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 NCT00357253.

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 10 Jan 2013.

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