GliomaPhase 2NCT00575796
Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)
A Phase 2 study testing Vinblastine Sulphate in people with Glioma, run by The Hospital for Sick Children at 17 sites in Canada.
Trial summary
The overall objective of this study is to determine the efficacy of weekly Vinblastine in chemotherapy naïve patients with progressive or incompletely resected paediatric low grade glioma, to generate estimates of the response rate, progression-free survival, toxicity and quality of daily living among the population… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Glioma
- What is being tested?
- Vinblastine Sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 17 sitesCanada
- Study dates
- Oct 2007to Oct 2019
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have been < 18 years of age when originally diagnosed.
- Histologic Diagnosis: Patients must have histologic verification of LGG at original diagnosis. Exceptions are optic pathway gliomas in children with neurofibromatosis or children with large hypothalamic tumours for which a diagnostic biopsy does not seem necessary. Patients with disseminated low grade glioma are eligible.
- Astrocytoma Variants: fibrillary, protoplasmic, gemistocytic, mixed
- Pilocytic Astrocytoma
- Pleomorphic Xanthoastrocytoma
- Infantile desmoplastic astrocytoma
Show all 19Show fewer
- Ganglioglioma
- Oligodendroglioma
- Mixed glioma (including oligo-astrocytoma)
- Pilomyxoid astrocytoma
- Performance Level :Patients must have an ECOG performance status of 0, 1 or 2 or a Lansky/Karnofsky score > 50
- Life expectancy: Patients must have a life expectancy of * 2 months.
- Prior Therapy: Patients are eligible at the time of diagnosis or first progression following treatment with surgery only.
- Measurable Disease: Patients must have measurable disease, documented by radiographic criteria.
- Concomitant Medications
- Steroids: Steroids may be used at the time of inclusion to control progressive symptoms.
- Anti-epileptic medications are permitted - levetiracetam (Keppra) or clobazam (Frisium) being the preferred anti-epileptic medications for chronic use reserving phenytoin and lorazepam for acute seizure control.
- Organ Function Requirements: All patients must have adequate organ and bone marrow function within 7 days of starting chemotherapy (ANC * 1.0 x 109/L /, and platelet count * 100 x 109/L (transfusion independent).
- Regulatory: All patients and/or their parents or legal guardians must sign a written informed consent and all institutional requirements for human studies must be met. This study is open to all participants regardless of gender or ethnicity.
Who cannot join
- Inclusion criteria are restrictive. Patient must meet all inclusion criteria.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2J3
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
McMaster University
Hamilton, Ontario, L8S 4J9
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Children's Hospital of Western Ontario
London, Ontario, N6C 2V5
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Centre Hospitalier Universitaire de Quebec
Sainte-Foy, Quebec, G1V 4G2
Saskatoon Cancer Center
Saskatoon, Saskatchewan, S7N 4H4
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, A1B 3V6
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
The overall objective of this study is to determine the efficacy of weekly Vinblastine in chemotherapy naïve patients with progressive or incompletely resected paediatric low grade glioma, to generate estimates of the response rate, progression-free survival, toxicity and quality of daily living among the population treated and determine biologic factors which will enable us to predict tumour behaviour.
Read the detailed description
Unresectable low grade glioma (LGG) of childhood increasingly appears as a chronic condition for which multiple treatments may be required. While several studies have shown evidence of short term tumour control with chemotherapy, the progression-free survival at 5 years is unsatisfactory. In addition, several regimens currently used for this condition are associated with significant risks of side effect and long term toxicity.
We have piloted in a single arm study the feasibility and efficacy of Vinblastine for children with recurrent and refractory low grade glioma, who have failed at least one line of treatment (chemotherapy and/or irradiation). Preliminary results show promising activity with minimal toxicity.
- Conditions
- Glioma
- Being tested
- Vinblastine Sulphate
- Keywords
- pediatrics, Low Grade Glioma, Vinblastine
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinblastine SulphateDrug
Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children will be treated with Vinblastine Sulphate chemotherapy via intravenous administration once a week over a period of 26 weeks. MRI disease evaluation should be performed at weeks 12 and 26 (+/- 1 week). If response on MRI at week 26 > stable (i.e. stable disease, objective or partial or complete response compared to the baseline MRI exam), continue weekly Vinblastine to the total duration of treatment (i.e. 70 weeks).
All children will be followed until they demonstrate clear signs tumour progression. Receives: Drug: Vinblastine Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate to weekly vinblastine
Measured: 70 Weeks
Secondary outcomes (4)
The progression-free survival with Vinblastine
Measured: At one year, two years and three years
The quality of daily life during treatment
Measured: 26 Weeks
The correlation of biological features of LGG with tumour behaviour
Measured: 5 years
To determine the role of telomere maintenance in the prognosis and evolution of PLGG
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Oncology Group of Ontario, Brain Tumour Program
- Responsible party
- Principal investigator, Ute Bartels, The Hospital for Sick Children
- Investigators
- Ute Bartels, MD, Principal investigator, The Hospital for Sick Children, Toronto CanadaBruce Crooks, MD, Study chair, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575796
- Sponsor's protocol ID
- 1000011227
- Status last verified
- Sep 2017
- First submitted
- 14 Dec 2007
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lassaletta A, Scheinemann K, Zelcer SM, Hukin J, Wilson BA, Jabado N, Carret AS, Lafay-Cousin L, Larouche V, Hawkins CE, Pond GR, Poskitt K, Keene D, Johnston DL, Eisenstat DD, Krishnatry R, Mistry M, Arnoldo A, Ramaswamy V, Huang A, Bartels U, Tabori U, Bouffet E. Phase II Weekly Vinblastine for Chemotherapy-Naive Children With Progressive Low-Grade Glioma: A Canadian Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2016 Oct 10;34(29):3537-3543. doi: 10.1200/JCO.2016.68.1585.
PubMed 27573663
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)
- ClinicalTrials.gov ID
- NCT00575796
- Acronym / sponsor ID
- 1000011227
- Conditions
- Glioma
- Keywords
- pediatrics, Low Grade Glioma, Vinblastine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Pediatric Oncology Group of Ontario, Brain Tumour Program
- Study start
- Oct 2007
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 18 Dec 2007 (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.
The overall objective of this study is to determine the efficacy of weekly Vinblastine in chemotherapy naïve patients with progressive or incompletely resected paediatric low grade glioma, to generate estimates of the response rate, progression-free survival, toxicity and quality of daily living among the population treated and determine biologic factors which will enable us to predict tumour behaviour.
Detailed description
Unresectable low grade glioma (LGG) of childhood increasingly appears as a chronic condition for which multiple treatments may be required. While several studies have shown evidence of short term tumour control with chemotherapy, the progression-free survival at 5 years is unsatisfactory. In addition, several regimens currently used for this condition are associated with significant risks of side effect and long term toxicity.
We have piloted in a single arm study the feasibility and efficacy of Vinblastine for children with recurrent and refractory low grade glioma, who have failed at least one line of treatment (chemotherapy and/or irradiation). Preliminary results show promising activity with minimal toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vinblastine SulphateChildren will be treated with Vinblastine Sulphate chemotherapy via intravenous administration once a week over a period of 26 weeks. MRI disease evaluation should be performed at weeks 12 and 26 (+/- 1 week). If response on MRI at week 26 > stable (i.e. stable disease, objective or partial or complete response compared to the baseline MRI exam), continue weekly Vinblastine to the total duration of treatment (i.e. 70 weeks). All children will be followed until they demonstrate clear signs tumour progression. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Patients must have been < 18 years of age when originally diagnosed.
- Histologic Diagnosis: Patients must have histologic verification of LGG at original diagnosis. Exceptions are optic pathway gliomas in children with neurofibromatosis or children with large hypothalamic tumours for which a diagnostic biopsy does not seem necessary. Patients with disseminated low grade glioma are eligible.
- Performance Level :Patients must have an ECOG performance status of 0, 1 or 2 or a Lansky/Karnofsky score > 50
- Life expectancy: Patients must have a life expectancy of * 2 months.
- Prior Therapy: Patients are eligible at the time of diagnosis or first progression following treatment with surgery only.
Key exclusion criteria (1 listed)
- Inclusion criteria are restrictive. Patient must meet all inclusion criteria.
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 SulphateVinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week. | Drug | 1 |
Primary outcome
The response rate to weekly vinblastine
Time frame: 70 Weeks
4 secondary outcomes
The progression-free survival with Vinblastine
Time frame: At one year, two years and three years
The quality of daily life during treatment
Time frame: 26 Weeks
The correlation of biological features of LGG with tumour behaviour
Time frame: 5 years
To determine the role of telomere maintenance in the prognosis and evolution of PLGG
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Derived from this study: PubMed 27573663Lassaletta A, Scheinemann K, Zelcer SM, Hukin J, Wilson BA, Jabado N, Carret AS, Lafay-Cousin L, Larouche V, Hawkins CE, Pond GR, Poskitt K, Keene D, Johnston DL, Eisenstat DD, Krishnatry R, Mistry M, Arnoldo A, Ramaswamy V, Huang A, Bartels U, Tabori U, Bouffet E. Phase II Weekly Vinblastine for Chemotherapy-Naive Children With Progressive Low-Grade Glioma: A Canadian Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2016 Oct 10;34(29):3537-3543. doi: 10.1200/JCO.2016.68.1585.
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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.
Ute Bartels, MD principal investigator
The Hospital for Sick Children, Toronto Canada
Bruce Crooks, MD study chair
IWK Health Centre
17 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 Vinblastine Sulphate in people with Glioma, run by The Hospital for Sick Children at 17 sites 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 19 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
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?
The response rate to weekly vinblastine (time frame: 70 Weeks). 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 NCT00575796, 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 20 Sep 2017.