Refractory Low-grade GliomasPhase 2VINILONCT01887522
Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults
A Phase 2 study testing Vinblastine + Nilotinib and Vinblastine in people with Refractory Low-grade Gliomas and Recurrent Low-grade Gliomas, run by Gustave Roussy, Cancer Campus, Grand Paris at 8 sites in 8 countries.
Trial summary
Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- Refractory Low-grade Gliomas, Recurrent Low-grade Gliomas
- What is being tested?
- Vinblastine + Nilotinib and Vinblastine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 6 Jul 2016to 25 Apr 2021
- 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 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent signed by the patient, or parents or legal representative and assent of the minor child.
- Age: 6 months to < 21 years of age at time of study entry
- Histologically confirmed low-grade glioma in non-NF1 patients (no further biopsy is needed at study entry). For patients with NF1, no biopsy is required to confirm the radiological diagnosis of the low grade glioma.
- Relapse or refractory tumor after at least one first-line therapy, not taking into account surgery only.
- Evaluable Disease on morphologic MRI
- Karnofsky performance status score >=70% for patients >12 years of age, or Lansky score >=70% for patients <=12 years of age, including patients with motor paresis due to disease.
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- Life expectancy >= 3 months.
- Adequate organ function:
- Adequate hematopoietic function: neutrophils ³1.0 x 109/L, platelets ³100 x 109/L; hemoglobin ³8 g/dL
- Adequate renal function: serum creatinine < 1.5 x ULN for age 0 - 1 year: <= 40 µmol/L
- 1 - 15 years: <= 65 µmol/L 15 - 20 years: <= 110 µmol/L In case serum creatinine >1.5 ULN according to age, creatinine clearance has to be >70 mL/min/1.73 m2 or glomerular filtration rate measurement >70% of the expected value
- Adequate electrolytes levels: potassium, magnesium, phosphor, total calcium Lower Limit of Normal (LLN)
- Adequate hepatic function: total bilirubin <=1.5 x ULN; AST and ALT <=2.5 x ULN.
- Absence of peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event, NCI CTCAE v4.0)
- Adequate cardiac function:
- Shortening Fraction (SF) >= 28% (35% for children <3 years) and Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline, as determined by echocardiography
- Absence of QTc prolongation (QTc > 450 msec on baseline ECG, using the QTcF formula) or other clinically significant ventricular or atrial arrhythmia
- Wash-out period of at least
- 3 weeks in case of preliminary chemotherapy,
- 6 weeks in case of nitrosourea-containing chemotherapy,
- 2 weeks in the case of treatment with vincristine only
- 6 weeks in case of radiation therapy
- Possibility of receiving the therapeutic schedule as indicated in the protocol
- Patients with reproductive potential must use effective contraception during their treatment and for up to 90 days after the last dose. Females with reproductive potential must have a negative pregnancy test <= 7 days before starting Nilotinib and/or Vinblastine.
- Patients already treated with one of the two drugs can be enrolled in the trial provided that rechallenging them with the same drug could be considered acceptable
Who cannot join
- Concomitant anti-tumor treatment
- Not recovered to <Grade 2 from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
- Known intolerance or hypersensitivity to Vinblastine
- Existence of another severe systemic disease
- Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines,
- Any concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the patient
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- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib.
- Simultaneous treatment with strong cytochromes P450 CYP3A4 inhibitors (e.g. antiepileptic drugs, see complete list in the Appendix 5).
- Simultaneous treatment with antiarrythmic drugs and other drugs known to prolong QT interval (cloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin, bepridil, cisapride and pimozide). A list of QT prolonging compounds can be found at http://www.azcert.org/medical-pros/druglists/drug-lists.cfm (Appendix 6)
- Impaired cardiac function including any one of the following:
- Clinically significant resting brachycardia (<50 beats per minute).
- QTc > 450 msec on baseline ECG. If QTc >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
- Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).
- History of or presence of clinically significant ventricular or atrial tachyarrhythmias (including congenital long QT syndrome or a known family history of congenital long QT syndrome)
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
United Kingdom1 site
Cancer Research UK Clinical Trials Unit School of Cancer Sciences University of Birmingham
Edgbaston, Birmingham, B15 2TT
About this study
Official title: Phase I-II Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults With Refractory or Recurrent Low-Grade Glioma
Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.
Read the detailed description
Low grade gliomas (LGG) are the most frequent brain tumor type in children. They are often chemosensitive. However, more than 50% of these tumors will progress within the first 5 years after the start of the treatment and need a second-line therapy. In most cases, patients are still young and the risk of side effects from radiation therapy will call for another medical treatment. If a tumor does not respond to first-line chemotherapy, the prognosis worsens with 25% of deaths within the first 5 years for optic gliomas. Vinblastine (Velbe®) is an effective drug for low grade gliomas with both antiproliferative and antiangiogenic effects. An update of the Canadian phase II of weekly vinblastine (6 mg/m²/week) reported one complete response (CR), three partial responses (PR) and 9 minor responses (MR) in the first 31 patients. The 1-year progressionfree survival (PFS) rate was 57%. Tolerance of the treatment is fair allowing prolonged maintenance therapy as in Langerhans cell histiocytosis and anaplastic large cell lymphoma (ALCL). These data encourage proceeding with further testing this approach in pediatric low-grade glioma.
Nilotinib is a tyrosine kinase inhibitor (TKI) known to affect c-Kit, DDR1 and the PDGF receptors alpha and beta. PDGF is a growth factor for normal and tumoral astrocytes and oligodendrocytes. In addition, PDGF receptors are expressed on pediatric low-grade glioma vessels. Tumor response to this class of TKI has been reported occasionally . When used as monotherapy, this class of TKI was well tolerated in children, including those with brain tumors. Taking advantage of their different antiangiogenic mechanisms, their limited and non-overlapping toxicities, vinblastine and nilotinib could play an interesting role in the treatment of pediatric low-grade glioma. Nilotinib via PDGFRA and c-kit interactions may also interfere with the stroma of the tumor which is a key factor for tumor growth as shown in the NF1 mouse model. Both drugs have also immunostimulating effects especially in dendritic cells, that will be explored during treatment in selected patients. Previous to the phase II assessing the efficacy of the combination compared to vinblastine as single agent, nilotinib and vinblastine have to be administered by escalating dosages in order to identify the recommended doses of each agent when given in combination. This phase I part of the trial is justified by a possible interaction of the two drugs that are substrates of cytochrome P450 CYP3A4. Initial/starting dose of nilotinib (115 mg/m² BID) will be 50% of the recommended dose when used as monotherapy in adults (800 mg/day: 400 mg BID =230 mg/m2 BID). Initial/starting dose of vinblastine will be 50% of the recommended dose when used as monotherapy or in association with other chemotherapeutic drugs (i.e. 3 mg/m2 once a week). This justifies obtaining pharmacokinetic data on both drugs when used in combination. A phase I trial evaluating nilotinib as single agent in pediatrics in hematological malignancies is ongoing, run by the ITCC and the COG group, exploring the dose-levels 230 mg/m² to 460 mg/m² BID. The results of this phase I trial, expected by 2012, and the data of the current trial will be considered to decide whether a higher dose-level for nilotinib can be opened (350 mg/m² BID).
- Being tested
- Vinblastine + Nilotinib, Vinblastine
- Keywords
- Children, Adolescents, Young Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinblastine + NilotinibDrug
- Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.
- Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28
VinblastineDrug
- Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| VINILO | Experimental | VINILO-arm: Vinblastine and nilotinib given in combination at the RD defined in the Phase I part:
* Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.
* Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28 Recommended doses of the drug combination will be reconsidered at an interim stage of the phase II trial after the analysis of the delayed toxicity encountered in the first 20 patients treated at the initial RD (adaptive design). Receives: Drug: Vinblastine + Nilotinib |
| Control Vinblastine only | Active comparator | Control Vinblastine only arm:
· Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.
Each 28-day cycle is repeated on Day 29/Day 1.
In both treatment groups, dose reductions and/or administration delays will be performed in case of severe hematological and/or non hematological toxicities while on treatment.
Vinblastine will be temporarily stopped in case of neutropenia <1 x109/L or thrombopenia <75 x 109/L. It could be re-started at a reduced dose after complete recovery.
Patients benefiting from study treatment may continue up to 12 cycles as long as the toxicity-benefit ratio is adequate. Receives: Drug: Vinblastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS computed as the time interval between the date of study entry and the date of tumor progression or death (whatever the cause of death). The progression will be defined either radiologically (>25% increase in two-dimension measurements or appearance of new lesions compared to the baseline or to the best response after initiation of therapy) or clinically by new symptoms related to tumor progression (significant decrease of visual acuity, new or worsening neurological deficit). Hydrocephaly is not considered as progression per se.
Measured: assessed up from randomization to tumor progression or death whatever the cause assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study start6 Jul 2016
- Primary completion20 Apr 2019
- Study completion25 Apr 2021
Why it stopped: the results of the interim analysis are clear with a significant advantage in terms of PFS in favor of the control arm (Vinblastine alone) over the investigational arm (Vinblastine + Nilotinib).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Low-grade GliomasStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Therapies For Children with Cancer Consortium
- Responsible party
- Sponsor
- Investigators
- Jacques GRILL, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887522
- Sponsor's protocol ID
- 2012-003005-10 Phase II
- Other IDs
- 2012/1883, 022
- Acronym
- VINILO
- Status last verified
- May 2022
- First submitted
- 19 Jun 2013
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults With Refractory or Recurrent Low-Grade Glioma
- ClinicalTrials.gov ID
- NCT01887522
- Acronym / sponsor ID
- VINILO / 2012-003005-10 Phase II
- Keywords
- Children, Adolescents, Young Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the results of the interim analysis are clear with a significant advantage in terms of PFS in favor of the control arm (Vinblastine alone) over the investigational arm (Vinblastine + Nilotinib).
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Innovative Therapies For Children with Cancer Consortium
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 27 Jun 2013 (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.
Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.
Detailed description
Low grade gliomas (LGG) are the most frequent brain tumor type in children. They are often chemosensitive. However, more than 50% of these tumors will progress within the first 5 years after the start of the treatment and need a second-line therapy. In most cases, patients are still young and the risk of side effects from radiation therapy will call for another medical treatment. If a tumor does not respond to first-line chemotherapy, the prognosis worsens with 25% of deaths within the first 5 years for optic gliomas. Vinblastine (Velbe®) is an effective drug for low grade gliomas with both antiproliferative and antiangiogenic effects. An update of the Canadian phase II of weekly vinblastine (6 mg/m²/week) reported one complete response (CR), three partial responses (PR) and 9 minor responses (MR) in the first 31 patients. The 1-year progressionfree survival (PFS) rate was 57%. Tolerance of the treatment is fair allowing prolonged maintenance therapy as in Langerhans cell histiocytosis and anaplastic large cell lymphoma (ALCL). These data encourage proceeding with further testing this approach in pediatric low-grade glioma.
Nilotinib is a tyrosine kinase inhibitor (TKI) known to affect c-Kit, DDR1 and the PDGF receptors alpha and beta. PDGF is a growth factor for normal and tumoral astrocytes and oligodendrocytes. In addition, PDGF receptors are expressed on pediatric low-grade glioma vessels. Tumor response to this class of TKI has been reported occasionally . When used as monotherapy, this class of TKI was well tolerated in children, including those with brain tumors. Taking advantage of their different antiangiogenic mechanisms, their limited and non-overlapping toxicities, vinblastine and nilotinib could play an interesting role in the treatment of pediatric low-grade glioma. Nilotinib via PDGFRA and c-kit interactions may also interfere with the stroma of the tumor which is a key factor for tumor growth as shown in the NF1 mouse model. Both drugs have also immunostimulating effects especially in dendritic cells, that will be explored during treatment in selected patients. Previous to the phase II assessing the efficacy of the combination compared to vinblastine as single agent, nilotinib and vinblastine have to be administered by escalating dosages in order to identify the recommended doses of each agent when given in combination. This phase I part of the trial is justified by a possible interaction of the two drugs that are substrates of cytochrome P450 CYP3A4. Initial/starting dose of nilotinib (115 mg/m² BID) will be 50% of the recommended dose when used as monotherapy in adults (800 mg/day: 400 mg BID =230 mg/m2 BID). Initial/starting dose of vinblastine will be 50% of the recommended dose when used as monotherapy or in association with other chemotherapeutic drugs (i.e. 3 mg/m2 once a week). This justifies obtaining pharmacokinetic data on both drugs when used in combination. A phase I trial evaluating nilotinib as single agent in pediatrics in hematological malignancies is ongoing, run by the ITCC and the COG group, exploring the dose-levels 230 mg/m² to 460 mg/m² BID. The results of this phase I trial, expected by 2012, and the data of the current trial will be considered to decide whether a higher dose-level for nilotinib can be opened (350 mg/m² BID).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VINILO | Experimental | Drug: Vinblastine + NilotinibVINILO-arm: Vinblastine and nilotinib given in combination at the RD defined in the Phase I part: * Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle. * Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28 Recommended doses of the drug combination will be reconsidered at an interim stage of the phase II trial after the analysis of the delayed toxicity encountered in the first 20 patients treated at the initial RD (adaptive design). |
| Control Vinblastine only | Active comparator | Drug: VinblastineControl Vinblastine only arm: · Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle. Each 28-day cycle is repeated on Day 29/Day 1. In both treatment groups, dose reductions and/or administration delays will be performed in case of severe hematological and/or non hematological toxicities while on treatment. Vinblastine will be temporarily stopped in case of neutropenia <1 x109/L or thrombopenia <75 x 109/L. It could be re-started at a reduced dose after complete recovery. Patients benefiting from study treatment may continue up to 12 cycles as long as the toxicity-benefit ratio is adequate. |
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- Written informed consent signed by the patient, or parents or legal representative and assent of the minor child.
- Age: 6 months to < 21 years of age at time of study entry
- Histologically confirmed low-grade glioma in non-NF1 patients (no further biopsy is needed at study entry). For patients with NF1, no biopsy is required to confirm the radiological diagnosis of the low grade glioma.
- Relapse or refractory tumor after at least one first-line therapy, not taking into account surgery only.
- Evaluable Disease on morphologic MRI
Key exclusion criteria (14 listed)
- Concomitant anti-tumor treatment
- Not recovered to <Grade 2 from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
- Known intolerance or hypersensitivity to Vinblastine
- Existence of another severe systemic disease
- Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines,
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 + Nilotinib* Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle. * Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28 | Drug | VINILO |
| Vinblastine· Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle. | Drug | Control Vinblastine only |
Primary outcome
Progression Free Survival (PFS)
Time frame: assessed up from randomization to tumor progression or death whatever the cause assessed up to 24 months
PFS computed as the time interval between the date of study entry and the date of tumor progression or death (whatever the cause of death). The progression will be defined either radiologically (>25% increase in two-dimension measurements or appearance of new lesions compared to the baseline or to the best response after initiation of therapy) or clinically by new symptoms related to tumor progression (significant decrease of visual acuity, new or worsening neurological deficit). Hydrocephaly is not considered as progression per se.
Results and safety
The study was stopped early (reason given: the results of the interim analysis are clear with a significant advantage in terms of PFS in favor of the control arm (Vinblastine alone) over the investigational arm (Vinblastine + Nilotinib).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Jacques GRILL, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinblastine + Nilotinib and Vinblastine in people with Refractory Low-grade Gliomas and Recurrent Low-grade Gliomas, run by Gustave Roussy, Cancer Campus, Grand Paris at 8 sites in 8 countries.
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 25 inclusion and 14 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: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, Denmark, France, Italy, Netherlands and 3 more countries. 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 was stopped early (reason given: the results of the interim analysis are clear with a significant advantage in terms of PFS in favor of the control arm (Vinblastine alone) over the investigational arm (Vinblastine + Nilotinib).). 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?
Progression Free Survival (PFS) (time frame: assessed up from randomization to tumor progression or death whatever the cause assessed up to 24 months). 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 31 May 2022.