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CTRI Number  CTRI/2025/03/082390 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Novel treatment for Recurrent High Grade Brain tumors 
Scientific Title of Study   Pilot Study for intra-tumoral administration of L- 2,4- Diamino-N-Butyric Acid Dihydrochloride (DAB) and Prazosin in 10 recurrent glioblastoma patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailesh A V Rao 
Designation  Professor and Head of the Department 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Neurosurgery, A-block, 3rd Floor, St. Johns Medical College Hospital Sarjapur Road Bangalore.

Bangalore
KARNATAKA
560034
India 
Phone  9845104035  
Fax    
Email  shailesh.rao@stjohns.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailesh A V Rao 
Designation  Professor and Head of the Department 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Neurosurgery, A-block, 3rd Floor, St. Johns Medical College Hospital Sarjapur Road Bangalore.

Bangalore
KARNATAKA
560034
India 
Phone  9845104035  
Fax    
Email  shailesh.rao@stjohns.in  
 
Details of Contact Person
Public Query  
Name  Dr Shailesh A V Rao 
Designation  Professor and Head of the Department 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Neurosurgery, A-block, 3rd Floor, St. Johns Medical College Hospital Sarjapur Road Bangalore.

Bangalore
KARNATAKA
560034
India 
Phone  9845104035  
Fax    
Email  shailesh.rao@stjohns.in  
 
Source of Monetary or Material Support  
Department of Neurosurgery, St Johns Medical College Hospital Sarjapur Road Bangalore 560034 
 
Primary Sponsor  
Name  St Johns Medical College Hospital 
Address  A-Block, 3rd Floor, St Johns Medical College Hospital, Sarjapur Road Bangalore 560034 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh AV  St Johns Medical College Hospital  Dept of Neurosurgery, A-Block, 3rd Floor, St Johns Medical College Hospital, Sarjapur Road Bangalore 560034
Bangalore
KARNATAKA 		 9845104035

shailesh.rao@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituti onal Ethics Committ ee, St John’s Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2,4 Diamino Butyricacid Dihydrochloride(DAB) and Prazosin  A novel treatment for recurrent glioblastoma that involves intra-tumoral administration of a a proprietary mixture of two drugs. Following Surgical tumour resection a catheter will be placed inside the tumour cavity. This will be used to administer DAB at a Concentration of 100 millimolar at pH 7.55, at a rate of 45 to 180ml/hour (depending on patients ICP) for 3 days. This is followed by a similar infusion of Prazosin at concentration of 25 micromolar at pH 7.55. Total duration of intervention is 5 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. histopathologically confirmed glioblastoma with MR evidence of neurosurgically significant recurrence
2. age between 18 and 75 years
3. any other existing inclusion criteria of the Neurosurgery Department of the hospital 
 
ExclusionCriteria 
Details  1. absence of informed consent
2. age outside the range for inclusion
3. extension of the lesion across the midline to the contralateral hemisphere
4. any other existing exclusion criteria of the Neurosurgery Department of the hospital 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
RANO(Response Assessment in Neuro-Oncology ) criteria of non recurrence 6 months post treatment  6 months post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Time to recurrence.
 		 Follow up MRI Brain at 6 Months post treatment & another at 12 Months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shaileshavrao@yahoo.com].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Elimination of High-grade Gliomas Through Induced Cytolysis, Elucidated by Two Patient Cases

CHRISTOS PANOTOPOULOS, GEORGE ATHANASIOU, STAVROS STAVROPOULOS, NICK BOUTOS, SHAILESH RAO, GEORGE PANAYOTOU, NEELAM K. VENKATARAMANA and GUNNAR RONQUIST
Anticancer Research January 2025, 45 (1) 201-207; DOI: https://doi.org/10.21873/anticanres.17405



Glioblastoma multiforme (GBM) is the most common and aggressive form of primary malignant tumors in the central nervous system of adults. In practice, all patients with GBM experience relapse, and treatment options become limited following first-line therapy. We previously reported a new, successful treatment approach for a GBM patient, implemented in direct conjunction with surgical intervention. Case Report: Here, we present an additional case demonstrating the success of this protocol, along with an overview of its underlying rationale and mechanisms. Following maximal safe tumor resection, our protocol involves the placement of two catheters in the tumor excision bed, connected to drug infusion pumps for continuous administration. The tumor’s excision beds are irrigated for 90-120 hours with a slightly alkaline Tris-buffered solution containing L-2,4 diaminobutyric acid, an unnatural amino acid, and Prazosin, a proapoptotic drug widely used as an antihypertensive. Both patients demonstrated marked clinical improvement. Recent contrast-enhanced magnetic resonance imaging revealed no evidence of malignancy, with Case 1 remaining disease-free for seven years and Case 2 for two years of follow-up. Conclusion: This innovative approach not only enhances local drug delivery but also minimizes systemic side effects, addressing a critical challenge in GBM treatment. These cases highlight the potential of this protocol as an adjunct to standard therapies, offering a promising option for managing inoperable or recurrent GBM. 
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