Clinical trial · Interventional
Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)
NCT00575796CI-TRIAL-00029609unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall objective of this study is to determine the efficacy of weekly Vinblastine in chemotherapy naïve patients with progressive or incompletely resected paediatric low grade glioma, to generate estimates of the response rate, progression-free survival, toxicity and quality of daily living among the population treated and determine biologic factors which will enable us to predict tumour behaviour.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinblastine Sulphate | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Children will be treated with Vinblastine Sulphate chemotherapy via intravenous administration once a week over a period of 26 weeks. MRI disease evaluation should be performed at weeks 12 and 26 (+/- 1 week). If response on MRI at week 26 \> stable (i.e. stable disease, objective or partial or complete response compared to the baseline MRI exam), continue weekly Vinblastine to the total duration of treatment (i.e. 70 weeks). All children will be followed until they demonstrate clear signs tumour progression.
- interventionNames
- Drug: Vinblastine Sulphate
Primary outcomes (1)
- measure
- The response rate to weekly vinblastine
- timeFrame
- 70 Weeks
Secondary outcomes (4)
- measure
- The progression-free survival with Vinblastine
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have been \< 18 years of age when originally diagnosed. 2. Histologic Diagnosis: Patients must have histologic verification of LGG at original diagnosis. Exceptions are optic pathway gliomas in children with neurofibromatosis or children with large hypothalamic tumours for which a diagnostic biopsy does not seem necessary. Patients with disseminated low grade glioma are eligible. 1. Astrocytoma Variants: fibrillary, protoplasmic, gemistocytic, mixed 2. Pilocytic Astrocytoma 3. Pleomorphic Xanthoastrocytoma 4. Infantile desmoplastic astrocytoma 5. Ganglioglioma 6. Oligodendroglioma 7. Mixed glioma (including oligo-astrocytoma) 8. Pilomyxoid astrocytoma 3. Performance Level :Patients must have an ECOG performance status of 0, 1 or 2 or a Lansky/Karnofsky score \> 50 4. Life expectancy: Patients must have a life expectancy of \* 2 months. 5. Prior Therapy: Patients are eligible at the time of diagnosis or first progression following treatment with surgery only. 6. Measurable Disease: Patients must have measurable disease, documented by radiographic criteria. 7. Concomitant Medications 1. Steroids: Steroids may be used at the time of inclusion to control progressive symptoms. 2. Anti-epileptic medications are permitted - levetiracetam (Keppra) or clobazam (Frisium) being the preferred anti-epileptic medications for chronic use reserving phenytoin and lorazepam for acute seizure control. 8. Organ Function Requirements: All patients must have adequate organ and bone marrow function within 7 days of starting chemotherapy (ANC \* 1.0 x 109/L /, and platelet count \* 100 x 109/L (transfusion independent). 9. Regulatory: All patients and/or their parents or legal guardians must sign a written informed consent and all institutional requirements for human studies must be met. This study is open to all participants regardless of gender or ethnicity. Exclusion Criteria: Inclusion criteria are restrictive. Patient must meet all inclusion criteria.
References
Publications (1)
- DERIVEDLassaletta A, Scheinemann K, Zelcer SM, Hukin J, Wilson BA, Jabado N, Carret AS, Lafay-Cousin L, Larouche V, Hawkins CE, Pond GR, Poskitt K, Keene D, Johnston DL, Eisenstat DD, Krishnatry R, Mistry M, Arnoldo A, Ramaswamy V, Huang A, Bartels U, Tabori U, Bouffet E. Phase II Weekly Vinblastine for Chemotherapy-Naive Children With Progressive Low-Grade Glioma: A Canadian Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2016 Oct 10;34(29):3537-3543. doi: 10.1200/JCO.2016.68.1585. PMID 27573663