Phase 2
N=12
Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
Low-grade Glioma
Bottom Line
View on ClinicalTrials.gov: NCT01497860 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Progression-free Survival — 23.1 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vinorelbine (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Eugene Hwang
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
23.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age: 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 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
Data sourced from ClinicalTrials.gov (NCT01497860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.