Phase 2 Study of Vinblastine in Children With Recurrent o... | NCT00213278

Studies
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma

NCT00213278

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Nov 20, 2014Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Glioma

Interventions

vinblastine sulphate injection

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2012Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2014

Last Update Posted Date

Nov 20, 2014Estimated

Name	Class
Ontario Cancer Research Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: vinblastine sulphate injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vinblastine sulphate injection	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine		52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Bouffet, MD	The Hospital for Sick Children, Toronto Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma
D001932	Brain Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014747	Vinblastine

Ancestor Terms

ID	Term
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided