Brain and Central Nervous System TumorsPhase 1NCT00005602
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
A Phase 1 study testing carboplatin, cereport and radiation therapy in people with Brain and Central Nervous System Tumors, run by Children's Oncology Group at 19 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy. 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?
- carboplatin, cereport and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2001to Sep 2005
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Newly diagnosed diffuse, intrinsic brain stem gliomas
- Measurable disease
- No disseminated disease at sites other than brain stem
- No neurofibromatosis
- Treatment must begin within 31 days of diagnosis
- Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy
PATIENT CHARACTERISTICS:
Age:
- 3 to 21
Performance status:
- Karnofsky 50-100% (over 10 years of age)
- Lansky 50-100% (10 years of age and under)
Life expectancy:
- At least 2 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications)
Renal:
- Creatinine less than ULN for age OR
- Creatinine clearance or glomerular filtration rate greater than 80 mL/min
Other:
- No history of severe allergic reaction to any platinum-containing compound
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent growth factors during therapy with carboplatin
Chemotherapy
- Not specified
Endocrine therapy
- Prior corticosteroids for brain stem glioma are allowed
Radiotherapy
- Not specified
Surgery
- Prior surgery for brain stem glioma is allowed
Other
- At least 24 hours since any of the following medications:
- Vasodilating compounds
- Angiotensin-converting enzyme inhibitors
- Calcium channel blockers
- Beta blockers
- No other prior therapy for brain stem glioma
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Albert Einstein Clinical Cancer Center
The Bronx, New York, 10461
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas.
- Determine the toxic effects of this treatment regimen in these patients.
- Assess the response to radiotherapy in patients treated with this regimen.
OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.
The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.
Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- carboplatin, cereport, radiation therapy
- Keywords
- untreated childhood brain stem glioma
- 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.
carboplatinDrug
Also called Paraplatin, CBDCA, NSC #241240
cereportDrug
Also called labradimil, IND #60315
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days | Experimental | Not described Receives: Drug: carboplatin; Drug: cereport; Radiation: radiation therapy |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days | Experimental | Not described Receives: Drug: carboplatin; Drug: cereport; Radiation: radiation therapy |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days | Experimental | Not described Receives: Drug: carboplatin; Drug: cereport; Radiation: radiation therapy |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days | Experimental | Not described Receives: Drug: carboplatin; Drug: cereport; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years
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 startFeb 2001
- Primary completionJan 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roger J. Packer, MD, Study chair, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005602
- Sponsor's protocol ID
- ADVL0012
- Other IDs
- COG-ADVL0012, CCG-ADVL0012, ALK-01-042, CCG-09802, CDR0000067715
- Status last verified
- Feb 2014
- First submitted
- 2 May 2000
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sibille A, Hendrick J, Cue Alvarez A, Ernst M, Seidel L, Duysinx B, Louis R, Corhay JL. Environmental and occupational exposure in newly diagnosed lung cancer - data from the PROTEON study. Expert Rev Respir Med. 2026 Sep 9:1-10. doi: 10.1080/17476348.2026.2729508. Online ahead of print.
PubMed 42708503
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
- ClinicalTrials.gov ID
- NCT00005602
- Acronym / sponsor ID
- ADVL0012
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- untreated childhood brain stem glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- Sep 2005 (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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas.
- Determine the toxic effects of this treatment regimen in these patients.
- Assess the response to radiotherapy in patients treated with this regimen.
OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.
The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.
Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 months.
Study design
- Primary purpose
- Treatment
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days | Experimental | Drug: carboplatin, Drug: cereport, Radiation: radiation therapy |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days | Experimental | Drug: carboplatin, Drug: cereport, Radiation: radiation therapy |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days | Experimental | Drug: carboplatin, Drug: cereport, Radiation: radiation therapy |
| Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days | Experimental | Drug: carboplatin, Drug: cereport, Radiation: radiation therapy |
Who may qualify
- Ages
- 3 to 21 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 |
|---|---|---|
| carboplatinAlso: Paraplatin, CBDCA, NSC #241240 | Drug | Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days |
| cereportAlso: labradimil, IND #60315 | Drug | Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days |
| radiation therapy | Radiation | Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days, Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days |
Primary outcome
Progression Free Survival
A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years
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 21 Feb 2014.
- Derived from this study: PubMed 42708503Sibille A, Hendrick J, Cue Alvarez A, Ernst M, Seidel L, Duysinx B, Louis R, Corhay JL. Environmental and occupational exposure in newly diagnosed lung cancer - data from the PROTEON study. Expert Rev Respir Med. 2026 Sep 9:1-10. doi: 10.1080/17476348.2026.2729508. Online ahead of print.
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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.
Roger J. Packer, MD study chair
Children's National Research Institute
19 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 carboplatin, cereport and radiation therapy in people with Brain and Central Nervous System Tumors, run by Children's Oncology Group at 19 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 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does the primary outcome measure?
Progression Free Survival. 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 NCT00005602, which also lists 1 linked publication.
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 21 Feb 2014; AzTrials last refreshed its copy on 8 Nov 2026.