A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma

NCT06016452 | Recruiting Phase 2 DMC

• 1 other identifier: 900970
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).

Conditions

Diffuse Glioma; Radionecrosis of Brain; High Grade Glioma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Response rates

  Clinical-radiological

  1 month post treatment with chlorophyllin

Secondary Outcomes (3)

• Survival Analysis

  3 months

• Health Questionnaire

  3 months

• Response rates

  3 months

Other Outcomes (1)

• Biological response rate

  3 months

Study Arms (2)

Stratum A (Symptomatic)

EXPERIMENTAL

Response rates at 1 month with a combination of steroids and CHL in this study is expected to be 65% as compared to the standard 50% response with the use of dexamethasone alone. For the study with an α of 0.1 and power of 80%,50 pts will be needed to achieve the desired output. In the first stage, 22 patients will be needed for assessment and continued to stage 2 if \>10 responses are seen.The stage 2 of the study will be considered successful if \>29 responses are achieved using the pre-specified response assessment criteria.Considering an attrition rate of 10% from lack of follow-up and another 10% for disease progression, an estimated 60 patients will be accrued in stratum A with the purpose of achieving 50 patients with endpoints available for analysis.

Drug: Chlorophyllin

Stratum B (Asymptomatic)

EXPERIMENTAL

This stratum includes pts without neurological worsening during imaging diagnosis of RN (asymptomatic RN).Approx 30% of patients continue to be neurologically/ radiologically stable or regression of imaging findings without need for further interventions (including corticosteroids).In the proposed study with the use of CHL, 45% patients are assumed to remain clinically and neurologically stable. With an α of 0.1 and power of 80%, 48 patients will be needed to achieve the desired outcome. In the first stage, 23 patients will be needed for assessment and continue to stage 2 if \>6 responses are seen. The phase 2 study will be considered successful if \>18 responses are achieved using the pre-specified response assessment criteria. Further considering an attrition rate of 10% from lack of follow-up and another 10% for disease progression, an estimated 58 patients will be accrued in stratum B with the purpose of achieving 48 patients with endpoints available for analysis.

Drug: Chlorophyllin

Interventions

Chlorophyllin DRUG

Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food coloring agent.

Also known as: Stratum A (Symptomatic), Stratum A (Asymptomatic)

Stratum A (Symptomatic); Stratum B (Asymptomatic)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of diffuse glioma.
• Radionecrosis on imaging with new neurological symptoms/ worsening of prior deficits (Stratum A) or
• without new symptoms (Stratum B).
• Karnofsky Performance Scale (KPS) ≥ 50.

You may not qualify if:

• No tissue diagnosis.
• KPS\< 50.
• Disease progression
• Contraindications to corticosteroids.
• Altered mental status with deficits in understanding or inability to consent to the study.
• Brainstem glioma
• Indeterminate for radionecrosis vs disease progression
• Prior treatment with bevacizumab (either for disease progression or radionecrosis)

Sponsors & Collaborators

• Tata Memorial Centre: lead
• Bhabha Atomic Research Centre (BARC): collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (1)

• Dasgupta A, Sawant S, Chatterjee A, Gota V, Sahu A, Choudhari A, Bhattacharya K, Puranik A, Dev I, Moiyadi A, Shetty P, Singh V, Menon N, Epari S, Sahay A, Shah A, Bano N, Shaikh F, Jirage A, Gupta T. Study Protocol of a Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma (CHROME). Cancer Med. 2025 Mar;14(5):e70657. doi: 10.1002/cam4.70657.

  PMID: 40025673 DERIVED

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

chlorophyllin

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Archya Dasgupta, MD

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Archya Dasgupta, MD, DNB

CONTACT

02224177000; archya1010@gmail.com

Tejpal Gupta, MD, DNB

CONTACT

drtejpalgupta@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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Model Details: The proposed phase II prospective study will be split into two strata: Stratum A (symptomatic RN) and Stratum B (asymptomatic RN).

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 29, 2023
• Study Start: November 13, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)