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| Name | Class |
|---|---|
| Pediatric Oncology Group of Ontario | OTHER |
| Brain Tumour Program | OTHER |
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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.
Unresectable low grade glioma (LGG) of childhood increasingly appears as a chronic condition for which multiple treatments may be required. While several studies have shown evidence of short term tumour control with chemotherapy, the progression-free survival at 5 years is unsatisfactory. In addition, several regimens currently used for this condition are associated with significant risks of side effect and long term toxicity.
We have piloted in a single arm study the feasibility and efficacy of Vinblastine for children with recurrent and refractory low grade glioma, who have failed at least one line of treatment (chemotherapy and/or irradiation). Preliminary results show promising activity with minimal toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinblastine Sulphate | Drug | Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The response rate to weekly vinblastine | 70 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The progression-free survival with Vinblastine | At one year, two years and three years | |
| The quality of daily life during treatment | 26 Weeks | |
| The correlation of biological features of LGG with tumour behaviour |
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Inclusion Criteria:
Patients must have been < 18 years of age when originally diagnosed.
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.
Performance Level :Patients must have an ECOG performance status of 0, 1 or 2 or a Lansky/Karnofsky score > 50
Life expectancy: Patients must have a life expectancy of * 2 months.
Prior Therapy: Patients are eligible at the time of diagnosis or first progression following treatment with surgery only.
Measurable Disease: Patients must have measurable disease, documented by radiographic criteria.
Concomitant Medications
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).
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ute Bartels, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Bruce Crooks, MD | IWK Health Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada | ||
| Stollery Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27573663 | Derived | Lassaletta 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. |
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| 5 years |
| To determine the role of telomere maintenance in the prognosis and evolution of PLGG | 5 years |
| Edmonton |
| Alberta |
| T6G 2J3 |
| Canada |
| Children's and Women's Health Centre of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Child Health Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster University | Hamilton | Ontario | L8S 4J9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital of Western Ontario | London | Ontario | N6C 2V5 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| Hospital Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier Universitaire de Quebec | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Center | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D014747 | Vinblastine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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