ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Nationwide Children's Hospital
Study ID
NCT05233397
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Adamantinomatous Craniopharyngioma
  • Recurrent Adamantinomatous Craniopharyngioma

Eligibility Criteria

Sex
ALL
Age
1 Year - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    For \< 30 kg: 12 mg/kg IV every 2 weeks; For ≥30 kg: 8 mg/kg IV every 2 weeks

Study Details

ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

Key Dates

Start date
Dec 16, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: Stratum 1 and Stratum 2
    Stratum 1: Patients with progressive or recurrent adamantinomatous craniopharyngiomas following radiation therapy. Stratum 2 (CLOSED): Patients with measurable adamantinomatous craniopharyngioma who have undergone surgery but have not previously received radiation therapy. Progressive disease is allowed but not required

Primary Outcome Measure

Sustained objective response rate of patients with recurrent/progressive previously irradiated ACP to treatment with systemic tocilizumab [ Time Frame: From Day 1 of treatment through 30 days following end of protocol treatment ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Holly Lindsay, MD
[email protected]
720-777-6740
Children's National Medical CenterWashington D.C.District of Columbia20010
Eugene Hwang, MD
[email protected]
202-476-5046
Nicklaus Children's HospitalMiamiFlorida33155-
Duke Children's HospitalDurhamNorth Carolina27710
Daniel Landi, MD
919-668-6688
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Peter de Blank, MD
[email protected]
513-517-2068
Nationwide Children's HospitalColumbusOhio43235
Maryam Fouladi, MD
[email protected]
614-722-5758
Texas Children's HospitalHoustonTexas77030
Patricia Baxter, MD
[email protected]
8328244681
Seattle Children's HospitalSeattleWashington98105
Rebecca Ronsley, MD, FRCPC
[email protected]
206-987-2106

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCNicklaus Children's Hospital· Miami, FLDuke Children's Hospital· Durham, NCCincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OH

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