Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Eugene Hwang
Study ID
NCT01497860
Phase
PHASE2
Status
Completed

Conditions

  • Low-grade Glioma

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.

Study Details

The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink or slow the growth of pediatric low-grade gliomas that have either returned or are continuing to grow. Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its therapeutic spectrum and decrease the neurotoxicity associated with related agents.

Key Dates

Start date
Jul 31, 2011
Status verified
Apr 2019
Primary completion
Jan 31, 2017
Completion
Jul 31, 2017

Study Design

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

Arms

  • Experimental: Vinorelbine
    IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National Medical CenterWashington D.C.District of Columbia20010-
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Washington D.C., DC

By research site
Children's National Medical Center· Washington D.C., DCMayo Clinic· Rochester, MN

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