AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 2NCT00360945

Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma

A Phase 2 study testing cisplatin, temozolomide and fluorescence in situ hybridization in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 23 sites in 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, 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. Read more about this study

Who is it for?
Ages 4 to 20 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
cisplatin, temozolomide and fluorescence in situ hybridization
Type of treatment
Surgery or procedure
How many people
87 participants
Where
23 sitesin 3 countries
Study dates
Apr 2004to 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 4 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors*:
  • Glioblastoma
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • Anaplastic ganglioglioma
  • Anaplastic mixed tumor
  • Glial component is essential NOTE: *Malignant gliomas occurring as a second primary malignancy allowed
  • Newly diagnosed or recurrent disease
  • No malignant brain stem tumors
  • Incompletely resected tumors
  • No completely resected tumors
  • Measurable or evaluable disease by conventional MRI

PATIENT CHARACTERISTICS:

  • Lansky performance status 40-100%
  • Organ toxicity ≤ grade 2
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Prothrombin ≥ 50%
  • Fibrinogen ≥ 1.5 g/L
  • Creatinine normal for age
  • Creatinine ≤ 65 µmol/L (4-15 years of age)
  • Creatinine ≤ 110 µmol/L (15-20 years of age)
  • Audiogram with toxicity grade ≤ 2
  • ECG normal
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No severe or life-threatening infection
  • No uncontrolled developing or symptomatic intracranial hypertension

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy for patients with relapsed disease
  • No prior cisplatin or temozolomide
  • No other concurrent anticancer therapy

Trial locations and contacts

23 sites in 3 countries.

23 sites in 3 countries

United Kingdom21 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

  • Bristol Royal Hospital for Children

    Bristol, England, BS2 8BJ

  • 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

  • Middlesex Hospital

    London, England, W1T 3AA

  • 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 University Hospital NHS Trust

    Southampton, England, SO16 6YD

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

France1 site

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Ireland1 site

  • Our Lady's Hospital for Sick Children Crumlin

    Dublin, 12

Other trials in Ireland

About this study

Official title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, 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.

PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate (complete and partial response) in pediatric patients with malignant gliomas treated with temozolomide and cisplatin.

Secondary

  • Identify genetic, metabolic, and proteomic profiles that will provide an insight into the molecular pathways involved in the pathogenesis of these tumors.
  • Link genetic changes with clinical details, histopathology, and patient outcome, thereby developing a biological basis for diagnosis, prognosis, and treatment monitoring.
  • Evaluate relapse-free survival at 1 and 2 years in patients treated at diagnosis.
  • Evaluate the duration of clinical response in patients treated at relapse.
  • Study the health status and quality of life of these patients.
  • Evaluate long-term toxicity of this therapeutic combination.
  • Evaluate the ability of magnetic resonance spectroscopy vs CT scan to predict response in patients with high-grade astrocytomas.

OUTLINE: This is a multicenter, open-label, nonrandomized, parallel-group study. Patients are stratified according to disease status (newly diagnosed vs relapsed). Patients with newly diagnosed disease are further stratified according to spread of disease (localized and measurable vs diffuse unmeasurable).

  • Stratum I (newly diagnosed disease): Patients receive CISTEM chemotherapy comprising cisplatin IV over 3 hours on day 1 and oral temozolomide once daily on days 2-6. Treatment repeats every 28 days for up to 7 courses. Patients who achieve responsive or stable disease after 2 courses receive 2 more courses of CISTEM chemotherapy and then undergo radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients may receive up to 3 more courses of CISTEM chemotherapy for a total of 7 courses.
  • Stratum II (relapsed disease): Patients receive CISTEM chemotherapy for up to 7 courses as in stratum I. Patients who reach the maximum dose allowed for cisplatin may receive oral temozolomide alone indefinitely.

Tissue and blood samples are obtained at baseline and examined by immunohistochemistry, fluorescent in situ hybridization (FISH), and loss of heterozygosity. The tumor tissue is analyzed for p53, MSH2, MLH1, and MGMT.

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

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.

Being tested
cisplatin, temozolomide, fluorescence in situ hybridization, loss of heterozygosity analysis, immunohistochemistry staining method
Keywords
childhood oligodendroglioma, untreated childhood cerebellar astrocytoma, childhood high-grade cerebral astrocytoma, childhood low-grade cerebral astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood brain tumor
Medical subject headings
Central Nervous System Neoplasms, Oligodendroglioma, Astrocytoma

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 after 2 courses

Secondary outcomes (4)

  1. Relapse-free survival

  2. Best response in patients receiving more than 2 courses

  3. Rate of progression at 6 months and 1 and 2 years

  4. Overall survival

Timeline

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

  1. First posted7 Aug 2006 (estimated)
  2. Study startApr 2004

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
Allocation
Non-randomised
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360945
Sponsor's protocol ID
CDR0000482280
Other IDs
CCLG-CNS-2004-02, EU-20622
Status last verified
Nov 2006
First submitted
3 Aug 2006
Last updated
17 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, temozolomide and fluorescence in situ hybridization in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 23 sites in 3 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 17 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 23 sites in United Kingdom, France, 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 after 2 courses. 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 NCT00360945.

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 17 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in