Clinical trial NCT00575796: Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)
Official title: Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioma
Keywords: pediatrics
Low Grade Glioma
Vinblastine
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Pediatric Oncology Group of Ontario
name: Brain Tumour Program
First posted: 2007-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The response rate to weekly vinblastine
timeFrame: 70 Weeks
Secondary outcomes:
measure: The progression-free survival with Vinblastine
timeFrame: At one year, two years and three years
measure: The quality of daily life during treatment
timeFrame: 26 Weeks
measure: The correlation of biological features of LGG with tumour behaviour
timeFrame: 5 years
measure: To determine the role of telomere maintenance in the prognosis and evolution of PLGG
timeFrame: 5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: St. John's
country: Canada
facility: Janeway Child Health Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hospital Sainte-Justine
state: Quebec
city: Sainte-Foy
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Ute Bartels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IWK Health Centre
name: Bruce Crooks, MD
role: STUDY_CHAIR
References:
citation: 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.