Cabozantinib With Topotecan-Cyclophosphamide

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04661852
Phase
PHASE1
Status
Completed

Conditions

  • Refractory Ewing Sarcoma
  • Refractory Osteosarcoma
  • Relapsed Ewing Sarcoma
  • Relapsed Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
6 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    PO (dose and schedule based upon dose level and nomogram)
  • Topotecan — DRUG
    IV, over 30 minutes (schedule based upon dose level)
  • Cyclophosphamide — DRUG
    IV, over 30 minutes (schedule based upon dose level)
  • Myeloid growth factor — DRUG
    subcutaneous filgrastim (daily until ANC ≥ 1,500/mm3 after nadir) or pegfilgrastim (once) must be given, with choice of agent per institutional standard or treating physician preference, starting on day 5, 6, 7 or 8 (depending upon chemotherapy timing)

Study Details

This research study is a clinical trial of a new combination of drugs as a possible treatment for relapsed/refractory Ewing sarcoma and/or osteosarcoma. * The names of the drugs are: * Cabozantinib * Topotecan * Cyclophosphamide * The names of the non-investigational supportive care drugs are: * Filgrastim, pegfilgrastim, or a related growth factor.

Key Dates

Start date
Dec 23, 2020
Status verified
Feb 2023
Primary completion
Oct 24, 2022
Completion
Oct 24, 2022

Study Design

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

Arms

  • Experimental: CABOZANTINIB WITH TOPOTECAN-CYCLOPHOSPHAMIDE
    Participants will be accrued to dose levels in cohorts of 3 using the 3 + 3 design with a combination of cabozantinib, topotecan and cyclophosphamide. * Each study treatment cycle lasts 21 days. * Participants may receive up to 17 cycles. * Participants will be assigned a specific dose and schedule of the study drugs determined when enrolled in the study.

Primary Outcome Measure

Maximum Tolerate Dose [ Time Frame: 1 Year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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