Brain MetastasisPhase 2CLQNCT01894633
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
A Phase 2 study testing Chloroquine and Total brain radiotherapy in people with Brain Metastasis, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 46 to 61 years
- Conditions the study is for
- Brain Metastasis
- What is being tested?
- Chloroquine and Total brain radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 80 years of age
- At leat one brain metastasis MRI
- KPS 70 or more
- RTOG-RPA I or II
- Basic Laboratory requirements
Who cannot join
- Candidates for radiosurgery, neurosurgery
- Patients treated with radiotherapy before entered to the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080
About this study
Official title: Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
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.
Read the detailed description
Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.
- Conditions
- Brain Metastasis
- Being tested
- Chloroquine, Total brain radiotherapy
- Keywords
- Prophylactic Cranial Irradiation, Metastasis, Cloroquine
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called Aralen
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine 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
Total brain radiotherapyRadiation
30 Gy in 10 daily fractions from Monday to Friday
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine, radiosensitizer | Experimental | 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. Receives: Drug: Chloroquine; Radiation: Total brain radiotherapy |
| Placebo | Placebo comparator | 30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days Receives: Radiation: Total brain radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria
Measured: Every third month after randomization until 24 months follow-up. Measured by brain MRI
Secondary outcomes (1)
Central Nervous System Progression Free Survival
Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria
Measured: From time to progression to 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionJan 2013
Why it stopped: terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar Arrieta, MD, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894633
- Sponsor's protocol ID
- CD-449-08
- Acronym
- CLQ
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2013
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
- ClinicalTrials.gov ID
- NCT01894633
- Acronym / sponsor ID
- CLQ / CD-449-08
- Conditions
- Brain Metastasis
- Keywords
- Prophylactic Cranial Irradiation, Metastasis, Cloroquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine, radiosensitizer | Experimental | Drug: Chloroquine, Radiation: Total brain radiotherapyThe 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. |
| Placebo | Placebo comparator | Radiation: Total brain radiotherapy30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days |
Who may qualify
- Ages
- 46 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 80 years of age
- At leat one brain metastasis MRI
- KPS 70 or more
- RTOG-RPA I or II
- Basic Laboratory requirements
Key exclusion criteria (2 listed)
- Candidates for radiosurgery, neurosurgery
- Patients treated with radiotherapy before entered to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroquineAlso: AralenThe patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine 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 | Drug | Chloroquine, radiosensitizer |
| Total brain radiotherapy30 Gy in 10 daily fractions from Monday to Friday | Radiation | Chloroquine, radiosensitizer, Placebo |
Primary outcome
Overall Response Rate
Time frame: Every third month after randomization until 24 months follow-up. Measured by brain MRI
Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria
1 secondary outcome
Central Nervous System Progression Free Survival
Time frame: From time to progression to 24 months follow up
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Arrieta, MD principal investigator
Instituto Nacional de Cancerologia, Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chloroquine and Total brain radiotherapy in people with Brain Metastasis, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Every third month after randomization until 24 months follow-up. Measured by brain MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.