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

Who is this study for? Patients with Diffuse Pontine Glioma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
Tata Memorial Hospital
RECRUITING
Mumbai
Contact Information
Primary
Rahul Krishnatry, Dr
krishnatry@gmail.com
022-24177000
Time Frame
Start Date: 2020-02-04
Estimated Completion Date: 2029-12
Participants
Target number of participants: 40
Treatments
Experimental: Concurrent low-dose Bevacizumab
Low-dose concurrent Bevacizumab with standard radiotherapy
Experimental: Ultra-low-dose RT
Ultra-low-dose RT
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov