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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00575796
• Other study ID #: 1000011227
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 14, 2007
• Last updated: September 19, 2017
• Start date: October 2007
• Est. completion date: October 2019

Study information

• Verified date: September 2017
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	Hospital Sainte-Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Centre Hospitalier Universitaire de Quebec	Sainte-Foy	Quebec
Canada	Saskatoon Cancer Center	Saskatoon	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Janeway Child Health Centre	St. John's	Newfoundland and Labrador
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Children's and Women's Health Centre of British Columbia	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Paediatric Oncology Institutions of the Canadian Paediatric Brain Tumour Program, Pediatric Oncology Group of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The response rate to weekly vinblastine		70 Weeks
Secondary	The progression-free survival with Vinblastine		At one year, two years and three years
Secondary	The quality of daily life during treatment		26 Weeks
Secondary	The correlation of biological features of LGG with tumour behaviour		5 years
Secondary	To determine the role of telomere maintenance in the prognosis and evolution of PLGG		5 years