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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pediatric Oncology Group of Ontario
Paediatric Oncology Institutions of the Canadian Paediatric Brain Tumour Program
Information provided by (Responsible Party):
Eric Bouffet, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00575796
First received: December 14, 2007
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Glioma
Drug: Vinblastine Sulphate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs)

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • The response rate to weekly vinblastine [ Time Frame: 70 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The progression-free survival with Vinblastine [ Time Frame: At one year, two years and three years ] [ Designated as safety issue: No ]
  • The quality of daily life during treatment [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • The correlation of biological features of LGG with tumour behaviour [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine the role of telomere maintenance in the prognosis and evolution of PLGG [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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

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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575796

Locations
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2J3
Canada, British Columbia
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4J9
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital of Western Ontario
London, Ontario, Canada, N6C 2V5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hospital Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire de Quebec
Sainte-Foy, Quebec, Canada, G1V 4G2
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
The Hospital for Sick Children
Pediatric Oncology Group of Ontario
Paediatric Oncology Institutions of the Canadian Paediatric Brain Tumour Program
Investigators
Study Chair: Eric Bouffet, MD The Hospital for Sick Children, Toronto Canada
Study Chair: Bruce Crooks, MD IWK Health Centre
  More Information

No publications provided

Responsible Party: Eric Bouffet, Section Head, Neuro-Oncology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00575796     History of Changes
Other Study ID Numbers: 1000011227
Study First Received: December 14, 2007
Last Updated: August 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Low Grade Glioma
Vinblastine

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014