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

Primary Purpose

Glioma

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Vinblastine Sulphate
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring pediatrics, Low Grade Glioma, Vinblastine

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alberta Children's Hospital
  • Stollery Children's Hospital
  • Children's and Women's Health Centre of British Columbia
  • CancerCare Manitoba
  • Janeway Child Health Centre
  • IWK Health Centre
  • McMaster University
  • Kingston General Hospital
  • Children's Hospital of Western Ontario
  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children
  • Montreal Children's Hospital
  • Hospital Sainte-Justine
  • Centre Hospitalier Universitaire de Quebec
  • Centre Hospitalier Universitaire de Sherbrooke
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm 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.

Outcomes

Primary Outcome Measures

The response rate to weekly vinblastine

Secondary Outcome Measures

The progression-free survival with Vinblastine
The quality of daily life during treatment
The correlation of biological features of LGG with tumour behaviour
To determine the role of telomere maintenance in the prognosis and evolution of PLGG

Full Information

First Posted
December 14, 2007
Last Updated
September 19, 2017
Sponsor
The Hospital for Sick Children
Collaborators
Pediatric Oncology Group of Ontario, Brain Tumour Program
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1. Study Identification

Unique Protocol Identification Number
NCT00575796
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Pediatric Oncology Group of Ontario, Brain Tumour Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
pediatrics, Low Grade Glioma, Vinblastine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vinblastine Sulphate
Intervention Description
Vinblastine dose: 6 mg/m2 (10 mg maximum dose) route intravenous administration once a week.
Primary Outcome Measure Information:
Title
The response rate to weekly vinblastine
Time Frame
70 Weeks
Secondary Outcome Measure Information:
Title
The progression-free survival with Vinblastine
Time Frame
At one year, two years and three years
Title
The quality of daily life during treatment
Time Frame
26 Weeks
Title
The correlation of biological features of LGG with tumour behaviour
Time Frame
5 years
Title
To determine the role of telomere maintenance in the prognosis and evolution of PLGG
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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 Steroids: Steroids may be used at the time of inclusion to control progressive symptoms. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ute Bartels, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Crooks, MD
Organizational Affiliation
IWK Health Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2J3
Country
Canada
Facility Name
Children's and Women's Health Centre of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Janeway Child Health Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4J9
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2V5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hospital Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Center
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27573663
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.
Results Reference
derived

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

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