- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213278
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
November 19, 2014 updated by: Eric Bouffet, The Hospital for Sick Children
A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital For Sick Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- < 21 years of age at original diagnosis
- histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
- evidence of tumor recurrence or progression by MRI or contrast CT
- Karnofsky and Lansky performance status of 0,1 or 2
- life expectancy of greater than or equal to 2 months
- adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
- absolute neutrophil count (ANC)> 1000/uL
- platelet count > 100,000/uL (transfusion independent)
- serum creatinine < 1.5 x normal for age
- written informed consent signed by subject and/or subject's parent/legal guardian
Exclusion Criteria:
- not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
- chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
- less than 7 days since the completion of therapy with a biologic agent
- less than 2 months since cranial/spinal radiation
- receiving a stable dose of dexamethasone for less than one week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks.
If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Time Frame: 52 weeks
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52 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
Time Frame: 52 weeks
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52 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Bouffet, MD, The Hospital for Sick Children, Toronto Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
November 20, 2014
Last Update Submitted That Met QC Criteria
November 19, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Vinblastine
Other Study ID Numbers
- 0020010429
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glioma
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Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationNot yet recruitingGlioma | Low-grade Glioma | Glioma, Malignant | Low Grade Glioma of Brain | Glioma IntracranialUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI); Food and Drug Administration (FDA)Active, not recruitingRecurrent Glioblastoma | Recurrent Malignant Glioma | Refractory Malignant Glioma | Recurrent WHO Grade III Glioma | Recurrent WHO Grade II Glioma | Refractory Glioblastoma | Refractory WHO Grade II Glioma | Refractory WHO Grade III GliomaUnited States
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Children's Hospital of PhiladelphiaBlue Earth Diagnostics, Inc; Dragon Master FoundationRecruitingGlioma | High Grade Glioma | Glioma, Malignant | Diffuse Glioma | Glioma IntracranialUnited States
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ChimerixActive, not recruitingGlioblastoma | Diffuse Midline Glioma | H3 K27M Glioma | Thalamic Glioma | Infratentorial Glioma | Basal Ganglia GliomaUnited States
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University of California, San FranciscoBeiGene USA, Inc.; Pacific Pediatric Neuro-Oncology ConsortiumRecruitingGlioblastoma | Malignant Glioma | Recurrent Glioblastoma | Recurrent WHO Grade III Glioma | WHO Grade III Glioma | IDH2 Gene Mutation | IDH1 Gene Mutation | Low Grade Glioma | Recurrent WHO Grade II Glioma | WHO Grade II GliomaUnited States
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National Cancer Institute (NCI)RecruitingGlioma | High Grade Glioma | Malignant Glioma | Gliomas | Low Grade GliomaUnited States
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Beijing Tiantan HospitalDuke UniversityUnknownGlioblastoma | High Grade Glioma | Glioma, Malignant | Glioma of BrainstemChina
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGlioblastoma | Malignant Glioma | WHO Grade III Glioma | Recurrent Glioma | Refractory GliomaUnited States
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Hospital del Río HortegaCompletedGlioma | Glioblastoma | Low-grade Glioma | Glioma, Malignant | High-grade GliomaSpain
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Sabine Mueller, MD, PhDPacific Pediatric Neuro-Oncology ConsortiumRecruitingGlioblastoma | Malignant Glioma | Recurrent Glioblastoma | Recurrent Malignant Glioma | Recurrent Grade III Glioma | Grade III GliomaUnited States, Australia, Israel, Switzerland
Clinical Trials on vinblastine sulphate injection
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The Hospital for Sick ChildrenPediatric Oncology Group of Ontario; Brain Tumour ProgramUnknown
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Eurofarma Laboratorios S.A.CompletedOsteoarthritis of the KneeBrazil
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The Hospital for Sick ChildrenSolving Kids' CancerCompletedSolid Tumors | Central Nervous System TumorsCanada, United States
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Ullevaal University HospitalUnknownPrimary and Secondary Osteoarthritis in HipNorway
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University of SydneyNational Health and Medical Research Council, AustraliaUnknown
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University of LausannePierre Fabre LaboratoriesCompletedFatigue | Iron DeficiencySwitzerland
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Gustave Roussy, Cancer Campus, Grand ParisInnovative Therapies For Children with Cancer ConsortiumTerminatedRefractory Low-grade Gliomas | Recurrent Low-grade GliomasAustria, Italy, France, Denmark, Netherlands, Spain, Switzerland, United Kingdom
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University of WestminsterGencor Pacific GroupCompletedIron Deficiency (Without Anemia)United Kingdom
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National Cancer Institute (NCI)CompletedNeurofibromatosis Type 1 | Cutaneous Neurofibroma | Optic Nerve GliomaUnited States
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Ottawa Hospital Research InstituteOntario Institute for Cancer Research; Intensity Therapeutics, Inc.Recruiting