Brain Stem Neoplasms, PrimaryPhase 2NCT00179881
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
A Phase 2 study testing Carboplatin, Thalomid and External Beam Radiation Therapy in people with Brain Stem Neoplasms, Primary and Neoplasms, Brain Stem, run by Ann & Robert H Lurie Children's Hospital of Chicago at 6 sites in United States.
Trial summary
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Brain Stem Neoplasms, Primary, Neoplasms, Brain Stem
- What is being tested?
- Carboplatin, Thalomid and External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 1999to Apr 2007
- 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
Who may be able to join
- Patients must be >/= 3 and </= 21 years of age.
- Patients must have a newly diagnosed or progressive brain stem tumor.
- If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
- Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
- Cervicomedullary junction tumors are ineligible.
- Patients with a diagnosis of NF-1 are ineligible.
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- Patients must be registered within 6 weeks from diagnosis or recurrence.
- Patients must have life expectancy > 6 weeks.
- Patients must have adequate hematologic and renal function: ANC >1,000/ul, platelets>100,000/ul and creatinine normal for age: </= 0.7 mg/dl (age 3-10yrs.), </= 1.0 mg/dl (11-12yrs.). and </= 1.2 (13-21yrs.).
- Written informed consent must be obtained according to institutional guidelines.
- Pregnant or nursing women are ineligible.
- Patients must be registered within 3 days prior to the start of protocol treatment. Patients must not start treatment until informed consent is given and the patient is registered. Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Medical Center
Dayton, Ohio, 45404
Children's Hospitals and Clinics
Minneapolis, Minnesota, 55404
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospitals and Clinics
Saint Paul, Minnesota, 55404
Washington University Medical Center
St Louis, Missouri, 63110
About this study
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.
This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
- Being tested
- Carboplatin, Thalomid, External Beam Radiation Therapy
- Keywords
- Brain stem glioma
- Medical subject headings
- Brain Stem Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
ThalomidDrug
External Beam Radiation TherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
To determine the toxicity of this drug regimen.
Secondary outcomes (2)
To determine whether the multi-agent chemotherapy regimen of thalidomide and carboplatin, in patients with recurrent brain stem gliomas will extend their survival as compared to historical controls.
To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 1999
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Stem Neoplasms, PrimaryStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stewart Goldman, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Stewart Goldman, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179881
- Sponsor's protocol ID
- CNS 1099
- Status last verified
- Feb 2019
- First submitted
- 12 Sep 2005
- Last updated
- 5 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
- ClinicalTrials.gov ID
- NCT00179881
- Acronym / sponsor ID
- CNS 1099
- Keywords
- Brain stem glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Sep 2005 (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.
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.
This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Patients must be >/= 3 and </= 21 years of age.
- Patients must have a newly diagnosed or progressive brain stem tumor.
- If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
- Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
- Cervicomedullary junction tumors are ineligible.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Carboplatin | Drug | – |
| Thalomid | Drug | – |
| External Beam Radiation Therapy | Procedure or surgery | – |
Primary outcome
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
To determine the toxicity of this drug regimen.
2 secondary outcomes
To determine whether the multi-agent chemotherapy regimen of thalidomide and carboplatin, in patients with recurrent brain stem gliomas will extend their survival as compared to historical controls.
To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.
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 5 Feb 2019.
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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.
Stewart Goldman, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Thalomid and External Beam Radiation Therapy in people with Brain Stem Neoplasms, Primary and Neoplasms, Brain Stem, run by Ann & Robert H Lurie Children's Hospital of Chicago at 6 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?
The sponsor lists 12 inclusion and 0 exclusion criteria. 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.. The study lists 3 primary outcomes in all. 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 5 Feb 2019.