Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
Eugene Hwang, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01497860
First received: December 16, 2011
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Low-grade Glioma
Drug: Weekly vinorelbine treatment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • 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 date off study. This will be assessed continually for 60 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessments [ Time Frame: Assessed yearly for the 60 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vinorelbine Drug: Weekly vinorelbine treatment
Vinorelbine will be administered IV once a week for 6 out of every 8 weeks. This will continue barring progression or unacceptable toxicity for at least one year.

Detailed Description:

Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments.

Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors.

In addition, the quality of life for children with low-grade gliomas is important and requires further study. This trial will incorporate an optional assessment using validated neuropsychological testing throughout treatment to evaluate the quality of life of the child being treated.

Objective: To test the efficacy of Vinorelbine in a larger number of children with pediatric low-grade glioma that has returned or continues to grow.

In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest. This cycle can then be repeated for up to 1-2 years if providing clinical benefit.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: < 18 years
  • Tumor: Progressive or recurrent low grade glioma, WHO grade 1 or 2 who have failed at least one form of 'conventional' non-surgical therapy
  • Histologic confirmation is required with the exception of optic pathway and brain stem gliomas. Patients are not required to have a re-operation at time of recurrence.
  • Patients with disseminated disease are eligible.
  • Children with neuro-fibromatosis and optic pathway or brainstem tumors are eligible but must have definitive radiologic or clinical evidence of progression
  • Patients must have evidence of measureable disease
  • Performance status: Karnofsky or Lansky performance status of >50%
  • Organ Function:
  • Adequate bone marrow function (ANC>1000/mm3, platelet count of >75,000/mm3, and hemoglobin > 8gm/dL) prior to starting therapy. Hemoglobin may be supported by transfusion
  • Adequate liver function (SGPT/ALT<2.5 times ULN and bilirubin < 1.5 times ULN) prior to starting therapy
  • Prior therapy:
  • May have had treatment including surgery, chemotherapy, or radiotherapy for any number of relapses prior to enrollment
  • Patients must have received their last fraction of radiotherapy >12 weeks prior to starting therapy
  • Previous Vincristine or Vinblastine exposure is allowable.

Exclusion Criteria:

  • No other significant medical illness that in the investigators' opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
  • Any other cancer (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
  • Patients of childbearing potential must not be pregnant or breast-feeding (vinorelbine is a pregnancy category D, no data on excretion in breastmilk)
  • Patients of childbearing or fathering potential must practice adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497860

Contacts
Contact: Eugene Hwang, MD 202-476-5046 ehwang@childrensnational.org
Contact: Alissa Mun 202-476-5546 amun@childrensnational.org

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Eugene Hwang, MD    202-476-5046    ehwang@childrensnational.org   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amulya Rao, MBBS    507-284-2652    NageswaraRao.Amulya@mayo.edu   
Principal Investigator: Amulya Rao, MBBS         
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Eugene Hwang, MD Children's Research Institute
  More Information

No publications provided

Responsible Party: Eugene Hwang, Assistant Professor, Pediatric Oncology, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01497860     History of Changes
Other Study ID Numbers: CNMC-VRL
Study First Received: December 16, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
pediatric
children
glioma
low-grade
vinorelbine
recurrent
progressive

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014