CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT04145349
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Desmoplastic Small Round Cell Tumor

Eligibility Criteria

Sex
ALL
Age
12 Months - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Ramucirumab — DRUG
    Administered IV
  • Cyclophosphamide — DRUG
    Administered orally
  • Vinorelbine — DRUG
    Administered IV

Study Details

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

Key Dates

Start date
Jan 22, 2020
Status verified
Dec 2025
Primary completion
Jun 14, 2024
Completion
Jan 23, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ramucirumab + Cyclophosphamide + Vinorelbine
    Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
  • Active Comparator: Cyclophosphamide + Vinorelbine
    Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Washington UniversitySt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZChildren's Hospital of Los Angeles· Los Angeles, CAChildren's National Medical Center· Washington D.C., DCWashington University· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYChildren's Hospital of Philadelphia (CHOP)· Philadelphia, PA

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