Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

Completed · Phase 2

Conditions studied: Low-grade Glioma

In brief

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.

Key facts

Study ID

NCT01497860

Run by

Eugene Hwang

People needed

13

Starts

2011-07-01

Expected to finish

2017-07-01

Last updated by the study team

2019-05-20

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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