Status:
COMPLETED
Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Lead Sponsor:
Eugene Hwang
Conditions:
Low-grade Glioma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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. Vino...
Detailed Description
Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01497860
Start Date
July 1 2011
End Date
July 1 2017
Last Update
May 20 2019
Active Locations (2)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
Mayo Clinic
Rochester, Minnesota, United States, 55905