Health Condition 1: C717- Malignant neoplasm of brain stem
Conditions
Interventions
Intervention1: Concurrent Low dose BEVACIZUMAB: Bevacizumab (BVZ) is a VEGF-specific recombinant, humanized monoclonal antibody that binds to and
inhibits vascular endothelial growth factor (VEGF) fro
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: TUMOR DIAGNOSIS-Newly diagnosed non-disseminated treatment naïve DIPG by classic clinical AND radiographic finding. 2.Age: Patient must be 3 to 18 years of age at the time of diagnosis. 3. PS-kps >12 4.Participants must have normal organ and marrow function as defined below within two weeks prior to enrollment:a.Hematological: Absolute neutrophil count >1000/mcl, PLATELETS >100000/mcl (transfusion independent),HB > 8gm/dL (can be transfused) b. Hepatic: Total bilirubin aminotransferase [SGPT (ALT)] and aspartate aminotransferase [SGOT (AST)] 70ml/min/1.73m2. The absence of clinically significant proteinuria as defined by a screening early morning urine (first sample) dipstick urinalysis of coagulation profile 5.Post-Biopsy patients allowed, but should not have evidence of hemorrhage 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 THE SATISFYING OTHER CRITERIA. For arm 2, there will be no restriction other than the usual criteria. 6 NO CONTRAINDICATION FOR GA FOR MRI. 7. WOULD NOT NEED GA FOR RT. 8. Ability to understand and the willingness to sign a written informed consent document by the parent or guardian if less than .
Exclusion criteria
Exclusion criteria: a.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 b.Patients with uncontrolled systemic hypertension/ Proteinuria with a urine protein (albumin)/creatinine ratio of >=1.0. c.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. d.Allergies: Patients with a history of allergic reaction to Chinese hamster ovary cell products, or other recombinant human antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival for the total enrolled patient population will be 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 the 12-month OS as 35%Timepoint: Survival- at the median follow up 12 months. Overall Survival- at 12 mnths | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance and inconvenience rates Treatment abandonment rates and number of hours spent in hospital in non-admitted patients and number of patients needing hospital admission due to toxicity will be recorded and compared in two arms recorded.Timepoint: At any point of time during the study period;Overall survival Overall survival in each arm as well as for overall cohort will be recordedTimepoint: 6, 12 month and 18 months.;Pattern of relapse- local versus disseminated progression will be documented for each arm and overall cohort for the patients with available MRI at progression.Timepoint: Progression will be documented for each arm and overall cohort for the patients with available MRI at progression.;Progression-free survival: at 6 months, 12 months, 18 months will be recorded for overall cohort and each arm separately at first progression only.Timepoint: Overall survival in each arm as well as for overall cohort will be recorded at 6, 12 month and 18 months.;Quality of Life The Qol scores will be calculated as per the routine OPD based collection of Health utilities index, a 40 item standard questionnaire, interviewer administered (trial coordinator) available in English and hindi for all patientsTimepoint: Pre-treatment, at completion and at each follow up till progression.;Steroid Use Total duration of steroid use will be recordedTimepoint: The steroid time will be recorded as per CRF forms till death. This will be recorded for overall cohort and each arm separately;Toxicity The documentation of highest grade of toxicity as per CTCAE v 4 and RTOG radiation toxicity.Timepoint: Acute toxicity (during and post therapy 3 months) and late toxicity ( 3 months post treatment completion. This will be recorded for overall cohort and each arm separately. | — |
Countries
India
Contacts
Public ContactDr Rahul Krishnatry
TATA MEMORIAL HOSPITAL
Outcome results
None listed