Brain and Central Nervous System TumorsPhase 1NCT00006247
SU5416 in Treating Children With Recurrent or Progressive Brain Tumors
A Phase 1 study testing semaxanib in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 9 sites in United States.
Trial summary
RATIONALE: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have recurrent or progressive brain tumors. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- semaxanib
- How many people
- 33 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2000to Mar 2006
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Histologically proven malignant recurrent or progressive brain tumor at initial presentation or at time of recurrence or progression for which no standard curative therapy exists Histologic verification for brainstem gliomas may be waived Bone marrow involvement allowed
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 60-100% Life expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm3* Platelet count greater than 75,000/mm3* Hemoglobin greater than 9 g/dL *Transfusion independent Hepatic: Bilirubin normal for age SGOT and SGPT less than 2.5 times normal for age PT/PTT no greater than 1.2 times upper limit of normal Albumin greater than 3 g/dL No overt hepatic disease Renal: Creatinine no greater than 1.5 times normal for age OR Glomerular filtration rate greater than 70 mL/min No overt renal disease Cardiovascular: No deep venous or arterial thrombosis within the past 3 months No history of myocardial infarction, severe or unstable angina, or severe peripheral vascular disease No overt cardiac disease No prior cerebral bleeds Pulmonary: No pulmonary embolism within the past 3 months No overt pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known allergies to paclitaxel or other agent that uses Cremophor EL No uncontrolled infection Neurological deficits allowed if stable for at least 1 week prior to study Greater than 3rd percentile weight for height
PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior bone marrow transplantation More than 1 week since prior growth factor(s) Chemotherapy: At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Concurrent dexamethasone allowed if dose stable for at least 1 week prior to study Radiotherapy: More than 3 months since prior craniospinal irradiation greater than 24 Gy More than 3 months since prior total body irradiation More than 2 weeks since prior focal irradiation to symptomatic metastatic sites No prior stereotactic radiosurgery Concurrent total body irradiation allowed Surgery: See Radiotherapy Other: No other concurrent anticancer or experimental drug therapy Concurrent anticonvulsant drugs allowed
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors
RATIONALE: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have recurrent or progressive brain tumors.
Read the detailed description
OBJECTIVES: I. Determine the qualitative and quantitative toxicity of SU5416 in pediatric patients with recurrent or progressive brain tumors. II. Determine the acute and chronic dose-limiting toxicity and cumulative toxicity of this regimen in these patients. III. Determine the maximum tolerated dose and pharmacokinetics of this regimen in this patient population. IV. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsant agents, on the pharmacokinetics of this regimen in these patients. V. Determine the efficacy, in a preliminary manner, of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no drugs or modest-induction drugs). Patients receive SU5416 IV over 1 hour twice a week for 6 weeks. Treatment repeats every 6 weeks for 17 courses (approximately 2 years) in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients in each stratum receive escalating doses of SU5416 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 every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- semaxanib
- Keywords
- childhood craniopharyngioma, childhood central nervous system germ cell tumor, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood ependymoma
- Medical subject headings
- Central Nervous System Neoplasms, Oligodendroglioma, Choroid Plexus Neoplasms, Astrocytoma, Medulloblastoma, Optic Nerve Glioma, Familial ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
Also called SU5416
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities of SU5416 in children and adolescents with refractory CNS malignancies
Dose limiting toxicities of SU5416 in children and adolescents receiving enzyme inducing anticonvulsant drugs and in those not receiving enzyme inducing anticonvulsant drugs
Measured: Six weeks
Pharmacokinetics of SU5416 and the effects of enzyme inducing anticonvulsant drugs on the pharmacokinetics
Secondary outcomes (1)
Tumor response to SU5416
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2003 (estimated)
- Study startAug 2000
- Primary completionJul 2003
- Study completionMar 2006
Why it stopped: The pharmaceutical company discontinued further development of SU5416.
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.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark W. Kieran, MD, PhD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006247
- Sponsor's protocol ID
- CDR0000068179
- Other IDs
- PBTC-002
- Status last verified
- Oct 2009
- First submitted
- 11 Sep 2000
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kieran MW, Supko JG, Wallace D, Fruscio R, Poussaint TY, Phillips P, Pollack I, Packer R, Boyett JM, Blaney S, Banerjee A, Geyer R, Friedman H, Goldman S, Kun LE, Macdonald T; Pediatric Brain Tumor Consortium. Phase I study of SU5416, a small molecule inhibitor of the vascular endothelial growth factor receptor (VEGFR) in refractory pediatric central nervous system tumors. Pediatr Blood Cancer. 2009 Feb;52(2):169-76. doi: 10.1002/pbc.21873.
PubMed 19065567
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors
- ClinicalTrials.gov ID
- NCT00006247
- Acronym / sponsor ID
- CDR0000068179
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood craniopharyngioma, childhood central nervous system germ cell tumor, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood cerebellar astrocytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The pharmaceutical company discontinued further development of SU5416.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pediatric Brain Tumor ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2000
- Primary completion
- Jul 2003 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 24 Dec 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: SU5416 may stop the growth of brain cancer cells by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the safety of delivering SU5416 in children who have recurrent or progressive brain tumors.
Detailed description
OBJECTIVES: I. Determine the qualitative and quantitative toxicity of SU5416 in pediatric patients with recurrent or progressive brain tumors. II. Determine the acute and chronic dose-limiting toxicity and cumulative toxicity of this regimen in these patients. III. Determine the maximum tolerated dose and pharmacokinetics of this regimen in this patient population. IV. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsant agents, on the pharmacokinetics of this regimen in these patients. V. Determine the efficacy, in a preliminary manner, of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no drugs or modest-induction drugs). Patients receive SU5416 IV over 1 hour twice a week for 6 weeks. Treatment repeats every 6 weeks for 17 courses (approximately 2 years) in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients in each stratum receive escalating doses of SU5416 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 every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up 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 |
|---|---|---|
| semaxanibAlso: SU5416 | Drug | – |
Primary outcome
Toxicities of SU5416 in children and adolescents with refractory CNS malignancies
Dose limiting toxicities of SU5416 in children and adolescents receiving enzyme inducing anticonvulsant drugs and in those not receiving enzyme inducing anticonvulsant drugs
Time frame: Six weeks
Pharmacokinetics of SU5416 and the effects of enzyme inducing anticonvulsant drugs on the pharmacokinetics
1 secondary outcome
Tumor response to SU5416
Results and safety
The study was stopped early (reason given: The pharmaceutical company discontinued further development of SU5416.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Results publication: PubMed 19065567Kieran MW, Supko JG, Wallace D, Fruscio R, Poussaint TY, Phillips P, Pollack I, Packer R, Boyett JM, Blaney S, Banerjee A, Geyer R, Friedman H, Goldman S, Kun LE, Macdonald T; Pediatric Brain Tumor Consortium. Phase I study of SU5416, a small molecule inhibitor of the vascular endothelial growth factor receptor (VEGFR) in refractory pediatric central nervous system tumors. Pediatr Blood Cancer. 2009 Feb;52(2):169-76. doi: 10.1002/pbc.21873.
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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.
Mark W. Kieran, MD, PhD study chair
Dana-Farber Cancer Institute
9 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 semaxanib in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 9 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: stopped early, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 was stopped early (reason given: The pharmaceutical company discontinued further development of SU5416.). 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?
Toxicities of SU5416 in children and adolescents with refractory CNS malignancies. 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?
On the ClinicalTrials.gov record for NCT00006247, 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 14 Oct 2009; AzTrials last refreshed its copy on 7 Nov 2026.