Trial Outcomes & Findings for Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas (NCT NCT01497860)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.

Results posted on

2019-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Vinorelbine Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vinorelbine n=12 Participants Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months. Patients recruited without incidence over a 2 year period.
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.5 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.

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.

Outcome measures

Outcome measures
Measure	Vinorelbine n=13 Participants 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. 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.
Progression-free Survival	23.1 percentage Interval 14.8 to 31.1

Adverse Events

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adverse Events n=13 participants at risk Neutropenia - Grade 4 (n=2) Thrombocytopenia - Grade 4 (n=1) Anemia - Grade 3 (n=2) Weight Loss - grade 2 (n=1)
General disorders weight loss	7.7% 1/13 • Number of events 1
Blood and lymphatic system disorders thrombocytopenia	7.7% 1/13 • Number of events 1
Blood and lymphatic system disorders neutropenia	15.4% 2/13 • Number of events 3
Blood and lymphatic system disorders anemia	15.4% 2/13 • Number of events 2

Additional Information

Associate Professor

Children's National Medical Center

Phone: 2024765046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place