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mTOR inhibitor

Everolimus for Acoustic Neuroma

Phase 2

Waitlist Available

Led By Marco Giovannini, MD, PhD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of NF2 by National Institutes of Health (NIH) criteria

Age ≥ 16 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 1 month (13 months)

Awards & highlights

Study Summary

This trial will test if RAD001 can help NF2 patients by either shrinking or slowing the growth of their vestibular schwannoma(s), as well as improve hearing ability.

Who is the study for?

This trial is for individuals aged 16 or older with Neurofibromatosis type 2 (NF2) who have seen their vestibular schwannoma grow in the last year. They must be able to undergo MRI scans, not be pregnant or breastfeeding, and have good organ function. People can't join if they've had other cancers recently, severe medical conditions, or are sensitive to everolimus.Check my eligibility

What is being tested?

The study tests RAD001 (everolimus), an oral medication approved for some tumors but not NF2-related ones. It aims to see if it can shrink or slow down tumor growth and improve hearing in NF2 patients.See study design

What are the potential side effects?

While specific side effects aren't listed here, drugs like RAD001 may cause immune system suppression leading to infections, mouth sores, skin issues, fatigue, digestive problems and could affect blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with NF2 according to NIH standards.

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I am 16 years old or older.

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My tumor has grown in the last year.

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I need help with my daily activities due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year, 1 month (13 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year, 1 month (13 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 1 month (13 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vestibular schwannoma volume

Secondary outcome measures

Hearing

Number of adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: RAD001 TreatmentExperimental Treatment1 Intervention

All subjects will be given RAD001 for 1 year (12 months).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,046 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,197,349 Total Patients Enrolled

Marco Giovannini, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

everolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01345136 — Phase 2

Neurofibromatosis Research Study Groups: RAD001 Treatment

Neurofibromatosis Clinical Trial 2023: everolimus Highlights & Side Effects. Trial Name: NCT01345136 — Phase 2

everolimus (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01345136 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to elderly participants?

"The parameters of this clinical trial necessitate that patients are between 16 and 65 years old. For individuals younger than 16 and older than 65, there are 57 trials available for the former demographic group, while 145 opportunities exist in the latter cohort."

Answered by AI

What risks does RAD001, everolimus pose to individuals receiving treatment?

"Our assessment of RAD001's safety was a 2, given that this is still in the Phase 2 trial stage and only limited evidence exists to back up its efficacy."

Answered by AI

Might I qualify to participate in this examination?

"This research is seeking four individuals between the ages of 16 and 65 with angle tumor. To qualify, they must be willing to comply with scheduled appointments, drug administration plan, lab tests, other trial protocols, and study restrictions; demonstrate a progressive VS growth in the past year; possess a World Health Organisation performance score higher than or equal to 2; and if female patients are capable of having children – no pregnancy nor breastfeeding should occur during their participation."

Answered by AI

Are there any available opportunities for individuals to join this clinical experiment?

"The data presented on clinicaltrials.gov suggests that this particular trial has ended its recruitment process, as the last update to it was posted in March 2022. Nonetheless, there are currently 180 other active trials searching for participants."

Answered by AI

What is the typical indication for RAD001, also known as everolimus?

"RAD001, otherwise known as everolimus, has been used to treat numerous medical conditions including kidney transplant rejection, Waldenstrom macroglobulinemia and lung related disorders."

Answered by AI

What is the total participant count of this research project?

"This investigation has concluded its patient recruitment phase. First posted on July 1st 2015 and last updated March 2nd 2022, it is no longer accepting applicants. However, there are currently 87 trials for angle tumors and 93 for RAD001/everolimus that are actively seeking participants."

Answered by AI

Recent research and studies

Neuro-OncologyJournal

Mtorc1 Inhibition Delays Growth of Neurofibromatosis Type 2 Schwannoma

Giovannini, Marco, Nicolas-Xavier Bonne, Jeremie Vitte, Fabrice Chareyre, Karo Tanaka, Rocky Adams, Laurel M. Fisher, et al.. 2014. “Mtorc1 Inhibition Delays Growth of Neurofibromatosis Type 2 Schwannoma”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/not242.

Journal of Neuro-OncologyJournal

Phase II Study of Mtorc1 Inhibition by Everolimus in Neurofibromatosis Type 2 Patients with Growing Vestibular Schwannomas

Goutagny, Stéphane, Eric Raymond, Marina Esposito-Farese, Stéphanie Trunet, Christian Mawrin, Daniele Bernardeschi, Béatrice Larroque, Olivier Sterkers, Marco Giovannini, and Michel Kalamarides. 2015. “Phase II Study of Mtorc1 Inhibition by Everolimus in Neurofibromatosis Type 2 Patients with Growing Vestibular Schwannomas”. Journal of Neuro-oncology. Springer Science and Business Media LLC. doi:10.1007/s11060-014-1710-0.

clinicaltrials.govStudy

Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

2015. "Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01345136.