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New treatment option for DIPG
Official title A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma
ClinicalTrials.gov ID: NCT04250064
What this study is testing
What is Bevacizumab Injection?
Bevacizumab Injection is an investigational medicine, given as an once-weekly, being studied as a potential treatment for dipg.
Also referred to as Concurrent low-dose Bevacizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- 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 \ /= 50 assessed at enrollment.
- Participants must have normal organ and marrow function as defined below within two weeks prior to enrollment:
- Hematological: Absolute neutrophil count \> 1,000/mcL, Platelets\> 100,000/mcL (transfusion independent), HB \> 8gm/dL (can be transfused)
You likely can't join if
- Other than those mentioned above,
- 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...
- 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...
- Allergies: Patients with a history of allergic reaction to Chinese hamster ovary cell products, or other recombinant human antibodies.
See the full eligibility criteria
- 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 \ /= 50 assessed at enrollment.
- Participants must have normal organ and marrow function as defined below within two weeks prior to enrollment:
- Hematological: Absolute neutrophil count \> 1,000/mcL, Platelets\> 100,000/mcL (transfusion independent), HB \> 8gm/dL (can be transfused)
- Hepatic: Total bilirubin \< 1.5 times the upper limit of normal; alanine aminotransferase [SGPT (ALT)] and aspartate aminotransferase [SGOT (AST)] \< 5 times the institutional upper limit of normal.
- Renal: Serum creatinine which is less than 1.5x the upper limit of institutional normal for age or Glomerular Filtration Rate (GFR) \> 70 ml/min/1.73m2.; The absence of clinically significant proteinuria as defined by a...
- Normal coagulation profile
- Post-Biopsy patients allowed, but should not have evidence of haemorrhage greater than 0.5cm intracranially and should satisfy this criterion within two to four weeks of biopsy to start treatment in Arm 1 if designated...
- No contra-indication for GA for MRI
- Would not need GA for RT in the hypofractionated subgroup (due to logistics).
- Ability to understand and the willingness to sign a written informed consent document by the parent or guardian and assent by the child as applicable and as per institutional policy.
- Other than those mentioned above,
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mumbai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mumbai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.