Metastatic CancerPhase 1NCT01018836
Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase 1 study testing riluzole and whole-brain radiation therapy in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- riluzole and whole-brain radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2013
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor
- Has ≥ 2 brain metastases as demonstrated by baseline MRI
- Patients with only 1 metastasis are eligible provided the metastasis is too large for radiosurgery and not amenable to surgical resection
- Not being considered for surgical resection
- Eligible to undergo whole-brain radiotherapy (WBRT)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,000/μL
- Platelet count ≥ 50,000/μL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT ≤ 1.5 times ULN
- INR ≤ 1.5 times ULN
- Sodium normal
- Thyroid-stimulating hormone normal
- Negative pregnancy test
- Fertile patients must use effective contraception before, during, and for ≥ 6 months after completion of study treatment
- No headaches, disequilibrium, vertigo, or dizziness
- No known history of hepatitis B or C
- No concurrent serious systemic disorder (including active infection) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
- No history of allergic reactions attributed to riluzole
PRIOR CONCURRENT THERAPY:
- No prior WBRT
- At least 2 weeks since prior systemic chemotherapy
- No systemic chemotherapy during and for ≥ 3 weeks after completion of WBRT
- Radiosurgical boosts to ≤ 3 metastases allowed, based on the discretion of the treating radiation oncologist
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given together with whole-brain radiation therapy in treating patients with brain metastases.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of riluzole that can be administered concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple brain metastases.
Secondary
- To determine the long-term toxicity of riluzole when administered with WBRT.
- To assess neurocognitive function before and after treatment with riluzole and WBRT.
- To determine the MRI response of brain metastasis after treatment with riluzole and WBRT.
- To compare survival of patients treated with riluzole and WBRT to published historical data for patients with brain metastases.
- To evaluate the response of brain metastasis to riluzole and WBRT as a function of the expression of glutamate receptors on the primary tumor specimen.
OUTLINE: This is a dose-escalation study of riluzole.
Patients receive oral riluzole twice daily beginning on day 0. Beginning within 2 days after the initiation of riluzole, patients undergo whole-brain radiotherapy for 15 fractions.
Patients undergo neurocognitive and quality-of-life assessments at baseline, at 5 weeks, and at 3 months.
Tumor tissue samples are collected for laboratory biomarker studies.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Being tested
- riluzole, whole-brain radiation therapy
- Keywords
- tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
riluzoleDrug
The first dose of Riluzole will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiation, Riluzole should be discontinued and steroids should be tapered over the course of 1-3 weeks, at the discretion of the treating physicians.
whole-brain radiation therapyRadiation
Standard whole brain irradiation will be carried out at 250 cGy per day fractions times 15 to a total dose of 3750 cGy using a standard opposed lateral helmet field with the inferior border inclusive of C1.
| Study group | Role | What they receive |
|---|---|---|
| Riluzole; Radiation Therapy | Experimental | Not described Receives: Drug: riluzole; Radiation: whole-brain radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of riluzole
Measured: 2.5 years
Secondary outcomes (5)
Long-term toxicity of riluzole
Measured: .25 years
Neurocognitive function before and after treatment
Measured: 2.5 years
MRI response of brain metastasis after treatment
Measured: 2.5 years
Survival
Measured: 2.5 years
Response of brain metastasis to treatment as a function of the expression of glutamate receptors
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bruce G. Haffty, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018836
- Sponsor's protocol ID
- 050808
- Other IDs
- CDR0000660044, P30CA072720
- Status last verified
- Apr 2014
- First submitted
- 24 Nov 2009
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
- ClinicalTrials.gov ID
- NCT01018836
- Acronym / sponsor ID
- 050808
- Keywords
- tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Nov 2009 (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.
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given together with whole-brain radiation therapy in treating patients with brain metastases.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of riluzole that can be administered concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple brain metastases.
Secondary
- To determine the long-term toxicity of riluzole when administered with WBRT.
- To assess neurocognitive function before and after treatment with riluzole and WBRT.
- To determine the MRI response of brain metastasis after treatment with riluzole and WBRT.
- To compare survival of patients treated with riluzole and WBRT to published historical data for patients with brain metastases.
- To evaluate the response of brain metastasis to riluzole and WBRT as a function of the expression of glutamate receptors on the primary tumor specimen.
OUTLINE: This is a dose-escalation study of riluzole.
Patients receive oral riluzole twice daily beginning on day 0. Beginning within 2 days after the initiation of riluzole, patients undergo whole-brain radiotherapy for 15 fractions.
Patients undergo neurocognitive and quality-of-life assessments at baseline, at 5 weeks, and at 3 months.
Tumor tissue samples are collected for laboratory biomarker studies.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Riluzole; Radiation Therapy | Experimental | Drug: riluzole, Radiation: whole-brain radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| riluzoleThe first dose of Riluzole will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiation, Riluzole should be discontinued and steroids should be tapered over the course of 1-3 weeks, at the discretion of the treating physicians. | Drug | Riluzole; Radiation Therapy |
| whole-brain radiation therapyStandard whole brain irradiation will be carried out at 250 cGy per day fractions times 15 to a total dose of 3750 cGy using a standard opposed lateral helmet field with the inferior border inclusive of C1. | Radiation | Riluzole; Radiation Therapy |
Primary outcome
Maximum tolerated dose of riluzole
Time frame: 2.5 years
5 secondary outcomes
Long-term toxicity of riluzole
Time frame: .25 years
Neurocognitive function before and after treatment
Time frame: 2.5 years
MRI response of brain metastasis after treatment
Time frame: 2.5 years
Survival
Time frame: 2.5 years
Response of brain metastasis to treatment as a function of the expression of glutamate receptors
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
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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.
Bruce G. Haffty, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing riluzole and whole-brain radiation therapy in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 May 2014. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Slow accrual). 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?
Maximum tolerated dose of riluzole (time frame: 2.5 years). 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 2 May 2014.