Brain and Central Nervous System TumorsPhase 2NCT00025077
Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
A Phase 2 study testing filgrastim, carboplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may shrink the tumor so that it can be removed during surgery or radiation therapy. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- filgrastim, carboplatin and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jan 2000to Apr 2011
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent medulloblastoma or supratentorial primitive neuroectodermal and pineal tumor
- Nodular/desmoplastic medulloblastoma
- Medullomyoblastoma
- Melanotic medulloblastoma
- Ependymoblastoma
- Pinealoblastoma
- Received prior craniospinal radiotherapy OR
- Relapse in site of prior localized radiotherapy (e.g., relapse after "baby brain" protocol)
PATIENT CHARACTERISTICS:
Age:
- Under 21
Performance status:
- Lansky 40-100% for ages 1-16 years
- Karnofsky 40-100% for ages over 16 years
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than upper limit of normal (ULN)
- AST less than 2 times ULN
Renal:
- Glomerular filtration rate at least 60 mL/min
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United Kingdom20 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, BS2 8BJ
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
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
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Great Ormond Street Hospital for Children NHS Trust
London, England, WC1N 3JH
University College of London Hospitals
London, England, WIT 3AA
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, M27 4HA
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
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
About this study
Official title: Treatment Of Recurrent Central Nervous System Primitive Neuroectodermal Tumors (PNETs) In Children And Adolescents A Strategy Including The Use Of High Dose Thiotepa And High Dose Carboplatin
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may shrink the tumor so that it can be removed during surgery or radiation therapy. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy and allow doctors to give higher doses of chemotherapy.
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa, carboplatin, and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors.
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Cytoreductive Phase: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 7 and continuing until blood counts recover. Treatment repeats after discontinuation of G-CSF for 2-4 courses. Peripheral blood stem cells (PBSC) are harvested after each course of cyclophosphamide. Patients undergo surgical resection or radiotherapy after the completion of chemotherapy. Patients achieving complete response proceed to myeloablative therapy.
- Myeloablative Phase: Patients receive thiotepa IV over 3 hours on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Beginning 2 days after the completion of G-CSF, patients receive carboplatin IV over 1 hour on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover.
Patients are followed at 1, 3, 6, and 12 months.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- filgrastim, carboplatin, cyclophosphamide, thiotepa, conventional surgery
- Keywords
- recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood medulloblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
cyclophosphamideDrug
thiotepaDrug
conventional surgeryProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Secondary outcomes (1)
Toxic death rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2000
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Barry Pizer, MD, Study chair, Royal Liverpool Children's Hospital, Alder Hey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025077
- Sponsor's protocol ID
- CCLG-CNS-2000-01
- Other IDs
- CDR0000068910, EU-20105
- Status last verified
- Jun 2007
- First submitted
- 11 Oct 2001
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Recurrent Central Nervous System Primitive Neuroectodermal Tumors (PNETs) In Children And Adolescents A Strategy Including The Use Of High Dose Thiotepa And High Dose Carboplatin
- ClinicalTrials.gov ID
- NCT00025077
- Acronym / sponsor ID
- CCLG-CNS-2000-01
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood medulloblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery or radiation therapy may shrink the tumor so that it can be removed during surgery or radiation therapy. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy and allow doctors to give higher doses of chemotherapy.
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.
Detailed description
OBJECTIVES:
- Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa, carboplatin, and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors.
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Cytoreductive Phase: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 7 and continuing until blood counts recover. Treatment repeats after discontinuation of G-CSF for 2-4 courses. Peripheral blood stem cells (PBSC) are harvested after each course of cyclophosphamide. Patients undergo surgical resection or radiotherapy after the completion of chemotherapy. Patients achieving complete response proceed to myeloablative therapy.
- Myeloablative Phase: Patients receive thiotepa IV over 3 hours on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Beginning 2 days after the completion of G-CSF, patients receive carboplatin IV over 1 hour on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover.
Patients are followed at 1, 3, 6, and 12 months.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| thiotepa | Drug | – |
| conventional surgery | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Event-free survival
1 secondary outcome
Toxic death rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Barry Pizer, MD study chair
Royal Liverpool Children's Hospital, Alder Hey
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, carboplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors, 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: finished, as of the sponsor's last update on 2 Aug 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?
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?
Event-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2013.