Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eugene Hwang
• Treatments: Vinblastine; Vinorelbine

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