Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Giselle Sholler
Study ID
NCT06540963
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Tipifarnib — DRUG
    Tablet
  • Naxitamab — DRUG
    IV

Study Details

The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing

Key Dates

Start date
Dec 6, 2024
Status verified
Apr 2026
Primary completion
Dec 1, 2030
Completion
Dec 1, 2035

Study Design

Enrollment
98 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HRNB Bone/Bone Marrow
    Cycles 1-6: Tipifarnib and Naxitamab Tipifarnib: on days 1-7 and 15-21 of each 28-day cycle. Naxitamab IV on Days 1, 3, and 5 of each cycle.
  • Experimental: HRNB All others
    Cycles 1-6: Tipifarnib and Naxitamab Tipifarnib: on days 1-7 and 15-21 of each 28-day cycle. Naxitamab IV on Days 1, 3, and 5 of each cycle.

Primary Outcome Measure

Determine the Overall Response Rate (ORR) of Participants using INSS Response [ Time Frame: 6 months ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202
Michael Bishop (PRINCIPAL_INVESTIGATOR)
Connecticut Children's HospitalHartfordConnecticut06106
Adam Barselau
[email protected]
Michael Isakoff (PRINCIPAL_INVESTIGATOR)
Nicklaus Children's HospitalMiamiFlorida33155
Aixa Guadarrama
[email protected]
Guillermo De Angulo (PRINCIPAL_INVESTIGATOR)
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Maria Frankos
[email protected]
Jamie Libes-Bander (PRINCIPAL_INVESTIGATOR)
Kapiolani Medical Center for Women and ChildrenHonoluluHawaii96813
Kelly Hutchins (PRINCIPAL_INVESTIGATOR)
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104
William Ferguson (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27708
Jessica Sun (PRINCIPAL_INVESTIGATOR)
Randall Children's HospitalPortlandOregon97227
Jason Glover (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical Center and Children's HospitalHersheyPennsylvania17033
Penn State Clinical Trials Group Email
[email protected]
Valerie Brown (PRINCIPAL_INVESTIGATOR)
Monroe Carrell Jr. Children's Hospital at VanderbiltNashvilleTennessee37232
Aida Constantinescu
[email protected]
Daniel Benedetti (PRINCIPAL_INVESTIGATOR)
Dell Children's Blood and Cancer CenterAustinTexas78723
Rhea Robinson
[email protected]
Virginia Harrod (PRINCIPAL_INVESTIGATOR)
Children's Medical CenterDallasTexas75235
Tanya Watt (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Arkansas Children's Hospital· Little Rock, ARConnecticut Children's Hospital· Hartford, CTNicklaus Children's Hospital· Miami, FLArnold Palmer Hospital for Children· Orlando, FLKapiolani Medical Center for Women and Children· Honolulu, HICardinal Glennon Children's Medical Center· St Louis, MO

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