Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

NCT01497860 | Completed Phase 2 Results DMC

• 1 other identifier: CNMC-VRL
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Low-grade Glioma

Keywords

pediatric; children; glioma; low-grade; vinorelbine; recurrent; progressive

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  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.

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

Study Arms (1)

Vinorelbine

EXPERIMENTAL

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.

Drug: Vinorelbine

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.

Also known as: Navelbine

Vinorelbine

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eugene Hwang: lead

Study Sites (2)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Glioma; Recurrence

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Associate Professor
• Organization: Children's National Medical Center

ehwang@childrensnational.org

2024765046

Study Officials

• Eugene Hwang, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Oncology

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 23, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 20, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-04

Locations

US (2)