Low-grade Glioma
Conditions
Keywords
pediatric, children, glioma, low-grade, vinorelbine, recurrent, progressive
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.
Interventions
DRUGVinorelbine
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.
Sponsors
Eugene Hwang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vinorelbine Patients with recurrent/progressive low-grade glioma, treatment six out of every eight weeks with IV vinorelbine for 12 months. Patients recruited without incidence over a 2 year period. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vinorelbine |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 6.5 years STANDARD_DEVIATION 3.6 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
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.
Time frame: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vinorelbine | Progression-free Survival | 23.1 percentage |