Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)

NCT00575796 | Unknown Phase 2 DMC

• 1 other identifier: 1000011227
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 17

Brief Summary

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

Glioma

Keywords

pediatrics; Low Grade Glioma; Vinblastine

Outcome Measures

Primary Outcomes (1)

• The response rate to weekly vinblastine

  70 Weeks

Secondary Outcomes (4)

• 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

  5 years

• To determine the role of telomere maintenance in the prognosis and evolution of PLGG

  5 years

Study Arms (1)

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.

Drug: Vinblastine Sulphate

Interventions

Vinblastine Sulphate DRUG

Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week.

1

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Astrocytoma Variants: fibrillary, protoplasmic, gemistocytic, mixed
• Pilocytic Astrocytoma
• Pleomorphic Xanthoastrocytoma
• Infantile desmoplastic astrocytoma
• Ganglioglioma
• Oligodendroglioma
• Mixed glioma (including oligo-astrocytoma)
• Pilomyxoid astrocytoma
• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Pediatric Oncology Group of Ontario: collaborator
• Brain Tumour Program: collaborator

Study Sites (17)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2J3, Canada

Location

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4J9, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6C 2V5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hospital Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Center

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 27573663 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

Vinblastine

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Ute Bartels, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

• Bruce Crooks, MD

  IWK Health Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Neuro-Oncology

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

CA (17)