Brain and Central Nervous System TumorsPhase 2NCT00313521
Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors
A Phase 2 study testing thiotepa, adjuvant therapy and radiation therapy in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as thiotepa, 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. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- thiotepa, adjuvant therapy and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 1995to Nov 1997
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following high-grade (malignant) astrocytic tumors:
- Anaplastic astrocytoma
- Glioblastoma
- Giant cell glioblastoma
- Gliosarcoma
- Any anatomical site except brain stem
- Newly diagnosed disease
- Has undergone tumor biopsy or surgical resection within the past 2 weeks
- Patients with post-operative residual disease (grade III or IV) are eligible
- Post-operative imaging of tumor within 72 hours of surgery
- Patients with no imageable post-operative disease are not eligible
- No neurological deterioration within 3 days of study treatment
- Increasing requirement for steroids to control symptoms of intracranial pressure is considered evidence of neurological deterioration
PATIENT CHARACTERISTICS:
- Lansky play score 40-100%
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Creatinine ≥ 1.5 times upper limit of normal
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
About this study
Official title: Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups
RATIONALE: Drugs used in chemotherapy, such as thiotepa, 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. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well thiotepa works together with radiation therapy in treating young patients with newly diagnosed malignant brain tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors.
Secondary
- Determine the acute and chronic toxicity of thiotepa in these patients.
- Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal fluid pharmacokinetics of thiotepa and tepa in these patients.
- Develop a phase II study framework model, to determine the chemosensitivity to new, single-agent regimens in the treatment of high-grade (malignant) astrocytic tumors, including anaplastic astrocytoma, glioblastoma, giant cell glioblastoma, and gliosarcoma.
- Determine the incidence of distant neuraxial metastases in patients at the time of relapse.
- Determine the 1-year disease-free survival rate in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by age (3-15 vs 16-20 years of age).
- Chemotherapy: Patients receive thiotepa IV continuously over 168 hours on days 1-7. Treatment repeats every 28 days for up to 2 courses. Patients then proceed to radiotherapy after blood counts recover.
- Radiotherapy: Patients undergo external-beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.
- Post-radiation chemotherapy: Patients with complete, partial, or objective response, or stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more courses at the discretion of the treating physician.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- thiotepa, adjuvant therapy, radiation therapy
- Keywords
- untreated childhood cerebellar astrocytoma, childhood high-grade cerebral 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.
thiotepaDrug
adjuvant therapyProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of surgical resection by surgical and radiological assessments
Secondary outcomes (1)
Tumor response to chemotherapy by imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startJun 1995
- Primary completionNov 1997 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- David A. Walker, Study chair, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313521
- Sponsor's protocol ID
- CDR0000454503
- Other IDs
- CCLG-9405, EU-20575, CCLG-CNS-1995-01
- Status last verified
- Dec 2006
- First submitted
- 11 Apr 2006
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups
- ClinicalTrials.gov ID
- NCT00313521
- Acronym / sponsor ID
- CDR0000454503
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- untreated childhood cerebellar astrocytoma, childhood high-grade cerebral astrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Jun 1995
- Primary completion
- Nov 1997 (estimated)
- First posted
- 12 Apr 2006 (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, such as thiotepa, 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. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well thiotepa works together with radiation therapy in treating young patients with newly diagnosed malignant brain tumors.
Detailed description
OBJECTIVES:
Primary
- Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors.
Secondary
- Determine the acute and chronic toxicity of thiotepa in these patients.
- Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal fluid pharmacokinetics of thiotepa and tepa in these patients.
- Develop a phase II study framework model, to determine the chemosensitivity to new, single-agent regimens in the treatment of high-grade (malignant) astrocytic tumors, including anaplastic astrocytoma, glioblastoma, giant cell glioblastoma, and gliosarcoma.
- Determine the incidence of distant neuraxial metastases in patients at the time of relapse.
- Determine the 1-year disease-free survival rate in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by age (3-15 vs 16-20 years of age).
- Chemotherapy: Patients receive thiotepa IV continuously over 168 hours on days 1-7. Treatment repeats every 28 days for up to 2 courses. Patients then proceed to radiotherapy after blood counts recover.
- Radiotherapy: Patients undergo external-beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.
- Post-radiation chemotherapy: Patients with complete, partial, or objective response, or stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more courses at the discretion of the treating physician.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 3 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 |
|---|---|---|
| thiotepa | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Degree of surgical resection by surgical and radiological assessments
1 secondary outcome
Tumor response to chemotherapy by imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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.
David A. Walker study chair
Queen's Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thiotepa, adjuvant therapy and radiation therapy in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group.
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.
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?
Degree of surgical resection by surgical and radiological assessments. 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 20 Sep 2013.