Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas (NCT01497860) | Clinical Trial Compass
CompletedPhase 2
Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
United States13 participantsStarted 2011-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.