Brain and Central Nervous System TumorsPhase 1NCT00053118
Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer
A Phase 1 study testing filgrastim, carboplatin and etoposide in people with Brain and Central Nervous System Tumors and Lymphoma, run by Roswell Park Cancer Institute at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma
- What is being tested?
- filgrastim, carboplatin and etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2002to Jul 2004
- Phase
- Phase 1
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary central nervous system malignancy
- Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen
PATIENT CHARACTERISTICS:
Age
- 18 and under at initial diagnosis
Performance status
- ECOG 0-2
Life expectancy
- At least 8 weeks
Hematopoietic
- Absolute neutrophil count greater than 750/mm^3
- WBC greater than 2,500/mm^3
- Platelet count greater than 100,000/mm^3
- No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect
Hepatic
- Liver function tests less than 2 times normal OR
- Absence of active hepatitis by liver biopsy
- Bilirubin less than 1.5 mg/dL
Renal
- Glomerular filtration rate greater than 60 mL/min by radionucleotide assay
Cardiovascular
- Ejection fraction at least 45%
Pulmonary
- Clinically normal pulmonary function (patients 5 years of age and under)
- FEV_1 and FVC at least 50% (patients over 5 years of age) OR
- Arterial blood gas normal and DLCO greater than 50%
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No mucositis or mucosal infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 3 weeks since prior systemic cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 6 months since prior radiotherapy to the pelvis or spine
Surgery
- Not specified
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies.
- Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is dose-escalation study of carboplatin.
Patients receive filgrastim (G-CSF) IV once daily for 6 days followed by a maximum of 5 apheresis sessions. If the target number of peripheral blood stem cells is not achieved, some patients receive G-CSF and undergo apheresis as above after a 2-week rest.
At least 3 days after completion of G-CSF, patients receive high-dose carboplatin IV over 1 hour on day 1, stem cell reinfusion on day 3, G-CSF subcutaneously on days 4-18 and 43-61, and oral etoposide 3 times daily on days 21-42. Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.
- Being tested
- filgrastim, carboplatin, etoposide, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation
- Keywords
- childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood craniopharyngioma, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent neuroblastoma, recurrent retinoblastoma, childhood visual pathway and hypothalamic glioma, childhood atypical teratoid/rhabdoid tumor, primary central nervous system non-Hodgkin lymphoma
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma, Neuroblastoma, Retinoblastoma, Choroid Plexus Neoplasms, Astrocytoma, Familial ependymoma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
IV
carboplatinDrug
IV
etoposideDrug
IV
bone marrow ablation with stem cell supportProcedure or surgery
IV
peripheral blood stem cell transplantationProcedure or surgery
IV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startMar 2002
- Primary completionJul 2004
- Study completionJul 2004
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.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Jean Bambach, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053118
- Sponsor's protocol ID
- CDR0000269284
- Other IDs
- RPCI-DS-00-03
- Status last verified
- Feb 2011
- First submitted
- 27 Jan 2003
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
- ClinicalTrials.gov ID
- NCT00053118
- Acronym / sponsor ID
- CDR0000269284
- Keywords
- childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood craniopharyngioma, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood brain stem glioma, recurrent childhood cerebellar astrocytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 28 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.
Detailed description
OBJECTIVES:
- Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies.
- Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is dose-escalation study of carboplatin.
Patients receive filgrastim (G-CSF) IV once daily for 6 days followed by a maximum of 5 apheresis sessions. If the target number of peripheral blood stem cells is not achieved, some patients receive G-CSF and undergo apheresis as above after a 2-week rest.
At least 3 days after completion of G-CSF, patients receive high-dose carboplatin IV over 1 hour on day 1, stem cell reinfusion on day 3, G-CSF subcutaneously on days 4-18 and 43-61, and oral etoposide 3 times daily on days 21-42. Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 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 |
|---|---|---|
| filgrastimIV | Biological | – |
| carboplatinIV | Drug | – |
| etoposideIV | Drug | – |
| bone marrow ablation with stem cell supportIV | Procedure or surgery | – |
| peripheral blood stem cell transplantationIV | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 1 Mar 2011.
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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.
Barbara Jean Bambach, MD study chair
Roswell Park Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, carboplatin and etoposide in people with Brain and Central Nervous System Tumors and Lymphoma, run by Roswell Park Cancer Institute at 3 sites in United States.
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 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 1 Mar 2011.