Vinblastine +/- Bevacizumab in Children With Unresectable or Progressive Low Grade Glioma (LGG)

Part of paid clinical trials in Los Angeles, California.

Sponsor
The Hospital for Sick Children
Study ID
NCT02840409
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Low Grade Glioma

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is an open-label, randomized, multi-center, comparator Phase II trial looking at the addition of Bevacizumab to Vinblastine in chemotherapy naïve pediatric patients with progressive Low Grade Glioma aged 6 months to less than18 years of age at the time of initiation of therapy. Participants will be randomized to Arm A or Arm B. Arm A includes 68 weeks of single agent Vinblastine administered once weekly IV. Arm B includes 68 weeks of Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered every two weeks IV for the initial 24 weeks. Randomization will take place at the time of registration taking into account NF1 and BRAF-KIAA1549-fusion status.

Key Dates

First listed
Jul 21, 2016
Start date
Aug 1, 2016
Status verified
Jan 2024
Primary completion
Jul 31, 2024
Completion
Aug 31, 2026

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    68 weeks of single agent Vinblastine administered once weekly IV
  • Experimental: Arm B
    68 weeks of Vinblastine administered weekly IV with the addition of 12 doses of Bevacizumab administered every two weeks IV for the initial 24 weeks.

Primary Outcome Measure

Efficacy of the addition of Bevacizumab to Vinblastine compared with Vinblastine alone in chemotherapy-naïve pediatric patients with unresectable or progressive Low Grade Gliomas as measured by Response Rate (RR). [ Time Frame: 6 months from randomization ]

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCChildren's Healthcare of Atlanta· Atlanta, GAThe Children's Hospital of Philadelphia· Philadelphia, PA

Related Studies