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Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

Primary Purpose

Low-grade Glioma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vinorelbine

About this trial

This is an interventional treatment trial for Low-grade Glioma focused on measuring pediatric, children, glioma, low-grade, vinorelbine, recurrent, progressive

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's National Medical Center
Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vinorelbine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01497860

First Posted

December 16, 2011

Last Updated

April 22, 2019

Sponsor

Eugene Hwang

1. Study Identification

Unique Protocol Identification Number

NCT01497860

Brief Title

Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

Official Title

Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eugene Hwang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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. Objective: To test the efficacy of Vinorelbine in 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 (6 of every 8 weeks) for one year. The patients will then be followed for 60 months. Progression free survival is the primary outcome and defined as the none of the following: greater a 20% increase in the sun of the longest diameter of the target lesion, or a measurable increase in a non-target lesion, or the appearance of new lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low-grade Glioma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vinorelbine

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Other Intervention Name(s)

Navelbine

Intervention Description

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 Information:

Title

Progression-free Survival

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugene Hwang, MD

Organizational Affiliation

Children's National Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

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