Clinical trial NCT01497860: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low-grade Glioma
Keywords: pediatric
children
glioma
low-grade
vinorelbine
recurrent
progressive
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 13
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Children's National Research Institute
name: Eugene Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: