MedTrace Logo

Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults

NCT01887522 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-05-31

No results posted yet for this study

Summary

Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.

Conditions

  • Refractory Low-grade Gliomas
  • Recurrent Low-grade Gliomas

Interventions

DRUG

Vinblastine + Nilotinib

* Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle. * Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28

DRUG

Vinblastine

· Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.

Sponsors & Collaborators

  • Innovative Therapies For Children with Cancer Consortium

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Jacques GRILL, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-06
Primary Completion
2019-04-20
Completion
2021-04-25

Countries

  • Austria
  • Denmark
  • France
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01887522 on ClinicalTrials.gov