GliomaPhase 2NCT00213278
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
A Phase 2 study testing vinblastine sulphate injection in people with Glioma, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Glioma
- What is being tested?
- vinblastine sulphate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2002to Sep 2012
- 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 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- < 21 years of age at original diagnosis
- histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
- evidence of tumor recurrence or progression by MRI or contrast CT
- Karnofsky and Lansky performance status of 0,1 or 2
- life expectancy of greater than or equal to 2 months
- adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
Show all 10Show fewer
- absolute neutrophil count (ANC)> 1000/uL
- platelet count > 100,000/uL (transfusion independent)
- serum creatinine < 1.5 x normal for age
- written informed consent signed by subject and/or subject's parent/legal guardian
Who cannot join
- not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
- chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
- less than 7 days since the completion of therapy with a biologic agent
- less than 2 months since cranial/spinal radiation
- receiving a stable dose of dexamethasone for less than one week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.
- Conditions
- Glioma
- Being tested
- vinblastine sulphate injection
- Keywords
- glioma, brain tumour, cancer, pediatrics, vinblastine sulfate
- Medical subject headings
- Glioma, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinblastine sulphate injectionDrug
Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: vinblastine sulphate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Measured: 52 weeks
Secondary outcomes (1)
To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Cancer Research Network
- Responsible party
- Principal investigator, Eric Bouffet, The Hospital for Sick Children
- Investigators
- Eric Bouffet, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213278
- Sponsor's protocol ID
- 0020010429
- Status last verified
- Nov 2014
- First submitted
- 13 Sep 2005
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
- ClinicalTrials.gov ID
- NCT00213278
- Acronym / sponsor ID
- 0020010429
- Conditions
- Glioma
- Keywords
- glioma, brain tumour, cancer, pediatrics, vinblastine sulfate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Ontario Cancer Research Network
- Study start
- Jan 2002
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 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.
This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vinblastine sulphate injection |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- < 21 years of age at original diagnosis
- histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
- evidence of tumor recurrence or progression by MRI or contrast CT
- Karnofsky and Lansky performance status of 0,1 or 2
- life expectancy of greater than or equal to 2 months
Key exclusion criteria (5 listed)
- not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
- chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
- less than 7 days since the completion of therapy with a biologic agent
- less than 2 months since cranial/spinal radiation
- receiving a stable dose of dexamethasone for less than one week
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 |
|---|---|---|
| vinblastine sulphate injectionVinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks. | Drug | 1 |
Primary outcome
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Time frame: 52 weeks
1 secondary outcome
To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
Time frame: 52 weeks
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 20 Nov 2014.
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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.
Eric Bouffet, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vinblastine sulphate injection in people with Glioma, run by The Hospital for Sick Children at 1 site in Canada.
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 10 inclusion and 5 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 the response rate to Vinblastine in recurrent low grade glioma of childhood (time frame: 52 weeks). 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 Nov 2014.