Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
HMeany
Study ID
NCT01518413
Phase
PHASE1
Status
Completed

Conditions

  • Brain Tumors
  • Ewing's Sarcoma Family of Tumors
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma and Other Soft Tissue Sarcomas

Eligibility Criteria

Sex
ALL
Age
2 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • sorafenib — DRUG
    sorafenib (50 and 200 mg tablets) orally twice daily, on a continuous schedule at a starting dose of 150mg/m2/dose.
  • irinotecan — DRUG
    irinotecan (70 mg/m2/dose) orally, concurrently, once daily,starting at the beginning of the 21 day cycle,repeated every 21 days

Study Details

The purpose of this study is to determine the safest and most effective oral dose combinations of sorafenib and irinotecan in pediatric patients with solid tumors, i.e. relapsed or refractory.

Key Dates

Start date
Dec 31, 2011
Status verified
Feb 2015
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy
    Three to 6 patient will be enrolled at each dose level and dose escalations will proceed in the absence of dose-limiting toxicity attributed to therapy, first with dose escalation of sorafenib and then, if tolerated, escalation of irinotecan.

Primary Outcome Measure

Toxicity Profile [ Time Frame: 24 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Children's National Medical CenterWashington D.C.District of Columbia20010-
National Cancer InstituteBethesdaMaryland20892-
Children's Hospital Boston/Dana-Farber Cancer InstituteBostonMassachusetts02215-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Washington D.C., DC

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's National Medical Center· Washington D.C., DCNational Cancer Institute· Bethesda, MDChildren's Hospital Boston/Dana-Farber Cancer Institute· Boston, MAThe Children's Hospital of Philadelphia· Philadelphia, PA

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