Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01497860
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01497860
Study Brief:
Protocol Section:
NCT01497860