Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Diagnosis: Pediatric Oncology, Pediatric Brain Tumor
NCT ID: NCT01497860
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-148
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.
Dana-Farber Cancer Institute, Children's Hospital Boston
Susan Chi, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
- 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
- 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
- Previous Vincristine or Vinblastine exposure is allowable.
- 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