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

NCT ID: NCT00575796

Last Updated: 2017-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2019-10-31

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.

Conditions

Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vinblastine Sulphate

Intervention Type: DRUG

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

Interventions

Vinblastine Sulphate

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pediatric Oncology Group of Ontario

OTHER

Sponsor Role: collaborator

Brain Tumour Program

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Ute Bartels

Staff Physician, Neuro-Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ute Bartels, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Bruce Crooks, MD

Role: STUDY_CHAIR

IWK Health Centre

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

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

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, 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

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Hospital Sainte-Justine

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Sainte-Foy, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27573663 (View on PubMed)

Other Identifiers

1000011227

Identifier Type: -

Identifier Source: org_study_id