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

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).

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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Sites (1)

• Tata Memorial Hospital, Mumbai, Maharashtra, India · RECRUITING