A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma

NCT04250064 | Recruiting Phase 2 DMC

• 1 other identifier: 3201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

DIPG

Outcome Measures

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%.

  median of 12 months from diagnosis

Secondary Outcomes (8)

• Progression-free survival

  6 months, 12 months, 18 months from diagnosis

• Adverse events

  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 years

• Steroid Use

  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 years

• Pattern of relapse

  from the date of enrollment on study to the last known follow-up date, assessed for up to 2 years

• Overall survival

  6, 12 month and 18 months.

Study Arms (2)

Concurrent low-dose Bevacizumab

EXPERIMENTAL

Low-dose concurrent Bevacizumab with standard radiotherapy

Drug: Bevacizumab Injection

Ultra-low-dose RT

EXPERIMENTAL

Ultra-low-dose RT

Radiation: Ultra-low-dose RT

Interventions

Bevacizumab Injection DRUG

Additional concurrent low-dose Bevacizumab with standard EBRT

Also known as: Concurrent low-dose Bevacizumab

Concurrent low-dose Bevacizumab

Ultra-low-dose RT RADIATION

Ultra-low-dose EBRT instead of standard dose RT

Ultra-low-dose RT

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 \< 12y \>/= 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 screening early morning urine (first sample) dipstick urinalysis of \< 2.
• 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 as per perfusion study along with satisfying other criteria as applicable. For arm 2, there will be no restriction other than the usual criteria.
• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rahul Krishnatry, Dr

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahul Krishnatry, Dr

CONTACT

022-24177000; krishnatry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 31, 2020
• Study Start: February 4, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

IN (1)