Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01709435
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Malignant Solid Neoplasm
  • Recurrent Melanoma
  • Recurrent Primary Central Nervous System Neoplasm
  • Recurrent Thyroid Gland Carcinoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Primary Central Nervous System Neoplasm
  • Thyroid Gland Medullary Carcinoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib S-malate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Nov 14, 2012
Status verified
Dec 2023
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

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

Arms

  • Experimental: Treatment (cabozantinib S-malate)
    Patients receive cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate [ Time Frame: Up to 28 days ]

Locations (22)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Children's Hospital of Orange CountyOrangeCalifornia92868-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
UCSF Medical Center-ParnassusSan FranciscoCalifornia94143-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of Atlanta - EglestonAtlantaGeorgia30322-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
Riley Hospital for ChildrenIndianapolisIndiana46202-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
C S Mott Children's HospitalAnn ArborMichigan48109-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Oncology GroupPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-
Children's Hospital of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Children's Hospital of Alabama· Birmingham, ALChildren's Hospital of Orange County· Orange, CAUCSF Medical Center-Mission Bay· San Francisco, CAUCSF Medical Center-Parnassus· San Francisco, CAChildren's National Medical Center· Washington D.C., DCChildren's Healthcare of Atlanta - Egleston· Atlanta, GA

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