A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma
ConditionDIPG
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-18
SponsorTata Memorial Centre
About this trial
In this study, the investigators are testing improvement in survival outcomes in DIPG patients when stratified with MR perfusion score and treated with the said protocol. Newly diagnosed DIPG patients will undergo MRI perfusion study in addition to the usual MRI at diagnosis and will be stratified into hyperperfused or hypoperfused tumours.
The hyperperfused patients will receive additional low dose Bevacizumab weekly with conventional standard radiotherapy.
The hypo-perfused patients will receive ultra-low-dose radiotherapy fractionation equivalent to conventional RT biological dose.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Tumour Diagnosis: Newly diagnosed non-disseminated treatment naïve DIPG by classic clinical AND radiographic finding.
Age: Patient must be 3 to 18 years of age at the time of diagnosis.
Performance Score: KPS > 12 y/o >/= 50 or LPS for < 12y >/= 50 assessed at enrollment.
Hematological: Absolute neutrophil count > 1,000/mcL, Platelets> 100,000/mcL (transfusion independent), HB > 8gm/dL (can be transfused)
Disqualifiers
Surgical Procedures: Patients who have had major surgery should not receive the first dose of BVZ until 28 days after major surgery or Serious or Non-Healing Wounds
Patients with uncontrolled systemic hypertension/ Proteinuria with a urine protein (albumin)/creatinine ratio of ≥1.0.
Thrombosis: Patients must not have been previously diagnosed with a deep venous or arterial thrombosis (including pulmonary embolism), and must not have a known thrombophilic condition.
Allergies: Patients with a history of allergic reaction to Chinese hamster ovary cell products, or other recombinant human antibodies.
Trial design
Design model
Parallel
Treatments tested in this trial
Bevacizumab Injection
DrugAdditional concurrent low-dose Bevacizumab with standard EBRT
Ultra-low-dose RT
RadiationUltra-low-dose EBRT instead of standard dose RT
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Concurrent low-dose BevacizumabExperimental treatment 1 intervention
Group B: Ultra-low-dose RTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival
Survival for the total enrolled patient population will calculated at the median follow up 12 months. This will be compared with historical data from TMH, international DIPG registry and SIOP DIPG registry for 12-month OS as 35%.
Time frame
median of 12 months from diagnosisSecondary outcomes
1
Progression-free survival
Progression-free survival: at 6 months, 12 months, 18 months will be recorded for overall cohort and each arm separately at first progression only. For the purpose of the study, any patient with two or more new clinical signs of neurological deterioration in accordance with classical DIPG diagnosis with radiological progression of disease from any previous available imaging will be called progression.
Time frame
6 months, 12 months, 18 months from diagnosis2
Adverse events
The documentation of highest grade of toxicity as per CTCAE v 4 and RTOG radiation toxicity.
Time frame
From the time of intervention beginning, through the course of intervention, at the end of intervention and follow up 3 monthly to the date of precluding progression, or last known follow-up date, assessed for up to 2 years3
Steroid Use
Total duration of steroid use will be recorded
Time frame
From the time of intervention beginning, through the course of intervention, at the end of intervention and follow up 3 monthly to the date of precluding progression, or last known follow-up date, assessed for up to 2 years4
Pattern of relapse
local versus disseminated progression will be documented for each arm and overall cohort for the patients with available MRI at progression.
Time frame
from the date of enrollment on study to the last known follow-up date, assessed for up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov