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AzTrials

Breast CancerPhase 1NCT00903214

Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer

A Phase 1 study testing riluzole, polymorphism analysis and axillary lymph node biopsy in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the growth of tumor cells. PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage IIIA breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
riluzole, polymorphism analysis and axillary lymph node biopsy
How many people
0 participants
Where
No sites listed yet
Study dates
May 2009to Jun 2011
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of adenocarcinoma of the breast
  • Stage I (T1c)-IIIA disease meeting the following criteria:
  • Large enough (> 1 cm) to undergo additional multiple core needle biopsies preoperatively
  • Surgically resectable for cure or palliation without first requiring neoadjuvant chemotherapy
  • Patients who have previously been treated for breast cancer, but are judged to have developed a new primary cancer, rather than a recurrence, are eligible

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 50,000/mm³
  • Liver function tests ≤ 3 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2 times ULN
  • Creatinine ≤ 1.5 mg/dL
  • INR ≤ 25% normal limits
  • Not pregnant or nursing
  • No known history of HIV or AIDS
  • No known history of hepatitis B or C
  • No history of vertigo or Ménière's type of disorder
  • No history of allergic reaction to riluzole or similar compounds

PRIOR CONCURRENT THERAPY:

  • No prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancer

About this study

Official title: Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the growth of tumor cells.

PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage IIIA breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the effects of glutamate receptor blockade with riluzole on cellular pathways important in the genesis and progression of disease in women with stage I-IIIA breast cancer by examining components of the mGluR1 signaling pathway in the pre- and post-treatment tumor samples to determine if glutamate blockade affects signaling through this pathway.

Secondary

  • To determine whether treatment with riluzole affects the proliferation and apoptosis in a manner suggesting a potential for therapeutic effectiveness.
  • To determine whether treatment with riluzole causes objectively measurable tumor shrinkage.

OUTLINE: Patients receive oral riluzole twice daily on days -14 to 0. Approximately 12 hours after completion of riluzole therapy patients undergo standard surgery (i.e., partial or total mastectomy) along with sentinel lymph node biopsy (for patients with node-negative disease) or full axillary dissection (for patients with node-positive disease) on day 0.

Patients undergo 3-dimensional image assessment at pre- and post-treatment by Computerized Ultrasound Risk Evaluation (C.U.R.E.).

Patients undergo core needle biopsy at baseline and during surgery for biomarker analysis (e.g., mGluR1) by IHC, western blotting, and RT-PCR. Blood samples are collected for GRM1 polymorphism analysis.

After completion of study treatment, patients are followed every 6 months for 1 year and then according to standard-of-care thereafter.

Conditions
Breast Cancer
Being tested
riluzole, polymorphism analysis, axillary lymph node biopsy, digital image analysis, needle biopsy
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • riluzoleDrug

    Also called RILUTEK

    100 mg orally twice a day, tablets self-administered, administered from day -14 to day 0 (scheduled surgery and preserve tissue for biormarker analysis)

  • polymorphism analysisGenetic

    Pre-treatment, day -15 but may be done any time after enrollment but before surgery.

  • axillary lymph node biopsyProcedure or surgery

  • digital image analysisProcedure or surgery

  • needle biopsyProcedure or surgery

  • sentinel lymph node biopsyProcedure or surgery

  • therapeutic conventional surgeryProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity

    Measured: Pre and Post-treatment with RILUTEK® (riluzole) administration

  2. Downregulation of phosphorylated ERK1/2

    Measured: Pre and Post treatment with RILUTEK® (riluzole) administration:

Secondary outcomes (2)

  1. Measures of proliferation, specifically mitotic rate and expression of Ki-67

    Measured: Pre and Post treatment with RILUTEK® (riluzole) administration:

  2. Measures of apoptosis, specifically levels of poly(ADP-ribose) polymerase (PAPR) cleavage and caspase III activity

    Measured: Pre and Post treatment with RILUTEK® (riluzole) administration:

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Funding ended

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903214
Sponsor's protocol ID
CDR0000641180
Other IDs
P30CA022453, WSU-2008-120
Status last verified
Apr 2013
First submitted
15 May 2009
Last updated
29 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing riluzole, polymorphism analysis and axillary lymph node biopsy in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute.

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: withdrawn, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity (time frame: Pre and Post-treatment with RILUTEK® (riluzole) administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00903214.

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 29 Apr 2013.

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