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Brain and Central Nervous System TumorsPhase 2NCT00281905

Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors

A Phase 2 study testing carboplatin, cisplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages Up to 3 years
What is being tested?
carboplatin, cisplatin and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
50 participants
Where
21 sitesin 2 countries
Study dates
Jun 1992to not given
Phase
Phase 2
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 Up to 3 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:
  • Brain stem tumor (histological confirmation not required)
  • Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:
  • Anaplastic (malignant) astrocytoma
  • Glioblastoma
  • Anaplastic (malignant) oligodendroglioma
  • Ependymoma
  • Anaplastic (malignant) ependymoma
  • Anaplastic (malignant) oligoastrocytoma
  • Choroid plexus carcinoma
  • Astroblastoma
  • Polar spongioblastoma
  • Gliomatosis cerebri
  • Anaplastic (malignant) ganglioglioma
  • Pineoblastoma
  • Mixed pineocytoma or pineoblastoma
  • Medulloepithelioma
  • Neuroblastoma
  • Ependymoblastoma
  • Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs
  • Has undergone surgery or biopsy of the tumor within the past 2-4 weeks

PATIENT CHARACTERISTICS:

  • No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • Prior steroids allowed
  • No concurrent steroids as anti-emetics
  • Concurrent steroids allowed for control of tumor-related symptoms

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United Kingdom20 sites

  • Royal Aberdeen Children's Hospital

    Aberdeen, Scotland, AB25 2ZG

  • Royal Belfast Hospital for Sick Children

    Belfast, Northern Ireland, BT12 6BE

  • Birmingham Children's Hospital

    Birmingham, England, B4 6NH

  • Institute of Child Health at University of Bristol

    Bristol, England, BS2 8AE

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • Childrens Hospital for Wales

    Cardiff, Wales, CF14 4XW

  • Royal Hospital for Sick Children

    Edinburgh, Scotland, EH9 1LF

  • Royal Hospital for Sick Children

    Glasgow, Scotland, G3 8SJ

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Liverpool Children's Hospital, Alder Hey

    Liverpool, England, L12 2AP

  • Royal London Hospital

    London, England, E1 1BB

  • Great Ormond Street Hospital for Children NHS Trust

    London, England, WC1N 3JH

  • Central Manchester and Manchester Children's University Hospitals NHS Trust

    Manchester, England, M27 4HA

  • Sir James Spence Institute of Child Health

    Newcastle upon Tyne, England, NE1 4LP

  • Queen's Medical Centre

    Nottingham, England, NG7 2UH

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Children's Hospital - Sheffield

    Sheffield, England, S10 2TH

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Ireland1 site

  • Our Lady's Hospital for Sick Children

    Dublin, 12

Other trials in Ireland

About this study

Official title: Management of Children Aged Less Than 3 Years With Brain Tumors

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after chemotherapy may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors.

Read the detailed description

OBJECTIVES:

  • Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.
  • Determine the event-free survival and overall survival in children treated with this regimen.
  • Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.
  • Determine the quality of life in children treated with this regimen.
  • Determine the tolerability and long-term toxicity of this regimen in these children.
  • Determine the proportion of children who require radiotherapy after treatment with this regimen.
  • Determine the prognosis of children who receive both chemotherapy and radiotherapy.
  • Determine the nature and behavior of brain tumors in very young children.

OUTLINE: This is a multicenter study.

  • Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43. Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.
  • Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.
  • Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.

Quality of life is assessed periodically.

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

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Keywords
untreated childhood brain stem glioma, childhood high-grade cerebral astrocytoma, childhood low-grade cerebral astrocytoma, untreated childhood cerebellar astrocytoma, childhood choroid plexus tumor, childhood infratentorial ependymoma, childhood supratentorial ependymoma, newly diagnosed childhood ependymoma, untreated childhood medulloblastoma, childhood oligodendroglioma, untreated childhood supratentorial primitive neuroectodermal tumor, disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma
Medical subject headings
Central Nervous System Neoplasms, Neuroblastoma, Astrocytoma, Choroid Plexus Neoplasms, Oligodendroglioma

What participants receive

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

What is being measured

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

  1. Response rate

  2. Event-free survival

  3. Local recurrence or occurrence of CNS metastases

  4. Quality of survival

  5. Tolerance

  6. Long-term toxicity

  7. Proportion of patients requiring radiotherapy

  8. Prognosis of children who receive both chemotherapy and radiotherapy

  9. Nature and behavior of brain tumors

Timeline

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

  1. First posted25 Jan 2006 (estimated)
  2. Study startJun 1992

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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281905
Sponsor's protocol ID
CDR0000454575
Other IDs
CCLG-CNS-9204, EU-20574, CCLG-CNS-1992-04
Status last verified
Jun 2007
First submitted
24 Jan 2006
Last updated
20 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, cisplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.

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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, Ireland. 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?

Results are not available in the source record.

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?

Response rate. The study lists 9 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 NCT00281905.

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 20 Sep 2013.

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