Evolutionary Therapy for Rhabdomyosarcoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04388839
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vincristine — DRUG
    IV push over 1 minute with dosing ranging from 0.24mg up to 1.5mg
  • Cyclophosphamide — DRUG
    IV over 60 minutes with dosing ranging from 220mg to 1200mg
  • Vinorelbine — DRUG
    IV push over 6-10 minutes with dosing ranging from 4mg-25mg
  • Actinomycin D — DRUG
    Actinomycin D should not be given with radiation. Will be administered through IV over 3-5 minutes with dosing ranging from 0.025mg-0.045mg
  • Cyclophosphamide Pill — DRUG
    Based on Body Surface Area (BSA) round to nearest 25mg

Study Details

This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

Key Dates

Start date
Dec 29, 2020
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - First Strike
    Participants will receive 42 weeks of conventional doses of vinorelbine, actinomycin D and cyclophosphamide
  • Experimental: Arm B - Second Strike - Maintenance
    Participants will receive conventional doses of Vincristine/Actinomycin D/Cyclophosphamide (VAC) until complete response (CR) for 12-42 weeks and then switch to up to 2 years of vinorelbine/oral cyclophoshamide
  • Experimental: Arm C - Adaptive Therapy
    Therapy with VAC that starts and stops based on response, adaptive timing of therapy, with a prolonged time to progression rather than complete remission goal
  • Active Comparator: Arm - D Conventional Therapy
    Participants will receive a chemotherapy combination based on published trials. An example would be 42 weeks of VAC but may also include irinotecan, doxorubicin, ifosfamide, etoposide.

Primary Outcome Measure

First Strike Event Free Survival [ Time Frame: Baseline to 3 years ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Comprehensive Cancer CenterBirminghamAlabama35294-
Children's Hospital of ColoradoAuroraColorado80045-
Connecticut Children's Medical CenterHartfordConnecticut06106-
University of FloridaGainesvilleFlorida32610-
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Moffitt Cancer CenterTampaFlorida33612-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Montefiore Medical Cancer CenterThe BronxNew York10467-
University of North Carolina Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Carolinas Medical Center, Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke Children's HospitalDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44106-
Nationwide Children's HospitalColumbusOhio43205-
Vanderbilt - Ingram Cancer CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD AndersonHoustonTexas77030-
Primary Children's Medical Center/UtahSalt Lake CityUtah84113-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Comprehensive Cancer Center· Birmingham, ALChildren's Hospital of Colorado· Aurora, COConnecticut Children's Medical Center· Hartford, CTUniversity of Florida· Gainesville, FLUniversity of Miami - Sylvester Comprehensive Cancer Center· Miami, FLJohns Hopkins All Children's Hospital· St. Petersburg, FL

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