Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05429502
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Topotecan — DRUG
    Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).
  • Temozolomide — DRUG
    Starting out dose of temozolomide for cohort A1 and A2 for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts, Cohort A3 and onwards, in Phase 1-Part A will initiate at 100mg/m2/day.
  • Ribociclib — DRUG
    Starting out dose of ribociclib for cohort A1 Phase 1-Part A: 200mg/m2/day. Starting out dose for Cohort A2 and A3 was 100mg/m2/day.

Study Details

This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT), and rhabdomyosarcoma (RMS).

Key Dates

Start date
Dec 27, 2022
Status verified
Oct 2025
Primary completion
Feb 26, 2025
Completion
Feb 26, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I-part A: Ribociclib + Topotecan and Temozolomide
    Participants with r/r NB, MB, HGG, MRT or RMS will be treated with ribociclib in combination with topotecan and temozolomide to determine MTD and/or RP2D. Ribociclib dose will be escalated with topotecan and temozolomide.

Primary Outcome Measure

Phase 1- Part A: Percentage of participants with Dose Limiting Toxicities (DLTs) in Cycle 1 [ Time Frame: Up to 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-
Cohen Children's Medical Center of New YorkNew Hyde ParkNew York11040-
St Jude s Childrens Research HospitalMemphisTennessee38105-2794-

Find similar trials in Boston, MA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Dana Farber Cancer Institute· Boston, MACohen Children's Medical Center of New York· New Hyde Park, NYSt Jude s Childrens Research Hospital· Memphis, TN

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