Low-grade Glioma Clinical Trial
Official title:
Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas
NCT number | NCT01497860 |
Other study ID # | CNMC-VRL |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | July 2017 |
Verified date | April 2019 |
Source | Children's Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Eugene Hwang |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months. | Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m. |
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