Clinical trial · Interventional
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): terminated
Summary
Brief summary (as posted)
Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chloroquine | Drug | Chloroquine | ALIAS |
| Total brain radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chloroquine, radiosensitizer
- description
- The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.
- interventionNames
- Drug: Chloroquine
- Radiation: Total brain radiotherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days
- interventionNames
- Radiation: Total brain radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 46 Years
- Maximum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: * 18 to 80 years of age * At leat one brain metastasis MRI * KPS 70 or more * RTOG-RPA I or II * Basic Laboratory requirements Exclusion Criteria: * Candidates for radiosurgery, neurosurgery * Patients treated with radiotherapy before entered to the study
References
Publications (0)
Data not yet available