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Brain and Central Nervous System TumorsPhase 2NCT00276666

Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery

A Phase 2 study testing cisplatin, lomustine and vincristine sulfate in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 22 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 The sponsor has not verified this record for over two years, so it may be out of date.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: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, vincristine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
cisplatin, lomustine and vincristine sulfate
Type of treatment
Surgery or procedure
How many people
29 participants
Where
22 sitesin 2 countries
Study dates
Nov 2001to Mar 2010
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 3 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically proven medulloblastoma
  • The following variants of medulloblastoma are also eligible:
  • Nodular/desmoplastic medulloblastoma
  • Medullomyoblastoma
  • Melanotic medulloblastoma
  • Metastatic disease, meeting at least 1 of the following criteria:
  • Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3)
  • Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery
  • Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin)
  • Underwent surgery to remove the tumor no more than 6 weeks ago

PATIENT CHARACTERISTICS:

  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Neurologically stable (or improving) during the week before starting radiotherapy
  • Lansky (1-16 years) or Karnofsky (>16 years) performance status 30-100%
  • No active infection
  • No prior malignant disease
  • Not pregnant or nursing
  • No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
  • Not require anesthesia
  • No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol

PRIOR CONCURRENT THERAPY:

  • No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy
  • No prior chemotherapy or radiotherapy
  • Dexamethasone should not be used as an anti-emetic unless other therapies fail

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 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

  • Addenbrooke's Hospital

    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

  • Cookridge Hospital

    Leeds, England, LS16 6QB

  • 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

    London, England, WC1N 3JH

  • Royal Manchester Children's Hospital

    Manchester, England, M27 4HA

  • Sir James Spence Institute of Child Health at Royal Victoria Infirmary

    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 - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Ireland1 site

  • Our Lady's Hospital for Sick Children Crumlin

    Dublin, 12

Other trials in Ireland

About this study

Official title: Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, vincristine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy after surgery may kill any tumor cells that remain.

PURPOSE: This phase II trial is studying giving radiation therapy together with combination chemotherapy to see how well it works in treating young patients with metastatic medulloblastoma who have undergone surgery.

Read the detailed description

OBJECTIVES:

  • Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in young patients with metastatic medulloblastoma.
  • Determine the toxicity of chemotherapy (vincristine during radiotherapy and 8 courses of lomustine, cisplatin, and vincristine after radiotherapy) in association with HART in these patients.

OUTLINE: This is a multicenter study.

  • Radiotherapy and vincristine: Beginning 4-6 weeks after surgery, patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. Patients also receive vincristine IV once weekly for 8 weeks beginning in week 1*. Approximately 6-8 weeks after completion of radiotherapy, patients proceed to maintenance chemotherapy.

NOTE: *The first 7 patients undergo radiotherapy without receiving vincristine

  • Maintenance chemotherapy: Patients receive oral lomustine once on day 1 and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Being tested
cisplatin, lomustine, vincristine sulfate, adjuvant therapy, radiation therapy
Keywords
untreated childhood medulloblastoma
Medical subject headings
Central Nervous System Neoplasms

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. Toxicity

Timeline

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

  1. First posted13 Jan 2006 (estimated)
  2. Study startNov 2001
  3. Primary completionMar 2010 (estimated)

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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276666
Sponsor's protocol ID
CDR0000454549
Other IDs
CCLG-CNS-2001-06, EU-20577
Status last verified
Jun 2009
First submitted
12 Jan 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, lomustine and vincristine sulfate in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 22 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 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 22 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?

Toxicity. 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 NCT00276666.

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.

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