Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of California, San Francisco
Study ID
NCT04485559
Phase
PHASE1
Status
Recruiting
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Conditions

  • High Grade Glioma
  • Low-grade Glioma
  • Recurrent World Health Organization (WHO) Grade II Glioma

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    Given PO
  • Trametinib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.

Key Dates

Start date
Dec 9, 2020
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trametinib, everolimus)
    Patients receive dosing per their assigned dose level. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of trametinib in combination with everolimus for both continuous and intermittent dosing schedules [ Time Frame: Up to 28 days ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, Children's of AlabamaBirminghamAlabama35233
Girish Dhall, MD
[email protected]
205-638-9285
Gregory Friedman, MD
[email protected]
Children's Hospital Los AngelesLos AngelesCalifornia90027
Ashley Margol, MD
[email protected]
(323) 361- 8147
Ashley Margol, MD (PRINCIPAL_INVESTIGATOR)
Tom Davidson, MD (SUB_INVESTIGATOR)
University of California, San Diego Rady Children's HospitalSan DiegoCalifornia92123
Jennifer Elster, MD
[email protected]
University of California, San FranciscoSan FranciscoCalifornia94143
PNOC Operations
[email protected]
415-502-1600
Sabine Mueller, MD, MPH
[email protected]
877-827-3222
Sabine Mueller, MD, PhD, MAS (PRINCIPAL_INVESTIGATOR)
Children's National Medical CenterWashington D.C.District of Columbia20010
Lindsay Kilburn, MD
[email protected]
202-476-5973
Lindsay Kilburn, MD (PRINCIPAL_INVESTIGATOR)
Roger Packer, MD (SUB_INVESTIGATOR)
University of FloridaGainesvilleFlorida32610-0265
Elias Sayour, MD, PhD
352-294-8347
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Angela Waanders, MD, MPH
[email protected]
(312) 227-4873
Riley Hospital for ChildrenIndianapolisIndiana46202
Scott Coven, DO, MPH
[email protected]
317-944-8784
Scott Coven, DO, MPH (PRINCIPAL_INVESTIGATOR)
Daniel Runco, MD, MS (SUB_INVESTIGATOR)
John Hopkins UniversityBaltimoreMaryland21287
Kenneth Cohen, MD, MBA
[email protected]
(410) 614-5055
Eric Raabe, MD, PhD
[email protected]
410-502-5157
Kenneth Cohen, MD, MBA (PRINCIPAL_INVESTIGATOR)
Eric Raabe, MD, PhD (SUB_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215-
Children's MinnesotaMinneapolisMinnesota55404
Anne Bendel, MD
[email protected]
(612) 626-2778
Anne Bendel, MD (PRINCIPAL_INVESTIGATOR)
Maggie Skrypek, MD (SUB_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
Mohamad AbdelBaki, MD
[email protected]
(314) 454-6018
Josh Rubin, MD, PhD
[email protected]
314-286-2790
Joseph M. Sanzari Children's Hospital at Hackensack University Medical CenterHackensackNew Jersey07601
Derek Hanson, MD
[email protected]
551-996-5437
Katharine Offer, MD
[email protected]
New York UniversityNew YorkNew York10016
Sharon Gardner, MD
[email protected]
(212) 263-9913
Doernbecher Children's Hospital Oregon Health & Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Cassie Kline, MD, MAS
[email protected]
(267) 426- 5026
Cassie Kline, MD, MAS (PRINCIPAL_INVESTIGATOR)
Jane Mintrum, MD, PhD (SUB_INVESTIGATOR)
University Of Texas Southwestern Medical CenterDallasTexas75235
Laura Klesse, MD
[email protected]
214-456-2382

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University of Alabama at Birmingham, Children's of Alabama· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CAUniversity of California, San Diego Rady Children's Hospital· San Diego, CAUniversity of California, San Francisco· San Francisco, CAChildren's National Medical Center· Washington D.C., DCUniversity of Florida· Gainesville, FL

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