A Pharmacokinetic and Pharmacodynamic Study of Vincristin... | NCT00001689

Studies
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia

NCT00001689

Sponsor

National Cancer Institute (NCI)

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

Phase

Phase 1

Conditions

Acute Lymphocytic Leukemia
Leukemia

Interventions

Vincristine

Countries

United States

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

ID	Type	Description	Link
98-C-0053

Status Module

Record Verification Date

Nov 2003

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 1998

Primary Completion Date

Not provided

Completion Date

Nov 2003

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

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

Mar 3, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Description Module

Brief Summary

The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

Detailed Description

The pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. The present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk ALL according to or on CCG protocols 1952/1962/1991. A limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. A correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

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 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Vincristine	Drug

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

All patients 1 year and less than 10 years of age.

Patient must be diagnosed with acute lymphoblastic leukemia.

All CCG patients must be enrolled on CCG 1952, 1962 or 1991 protocols, or be treated according to a CCG standard risk ALL protocol. NCI patients must be treated according to CCG 1952 for the treatment of standard risk ALL. Enrollment onto the current trial (CCG B9802) should if possible take place concurrently with enrollment onto 1952/1962/1991 or start of treatment according to a CCG standard risk ALL protocol.

All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.

EXCLUSION CRITERIA:

Previous underlying peripheral neuropathy.

Previous underlying central nervous system dysfunction.

Children with CNS toxicity attributable to other chemotherapeutic agents will not be followed with the Purdue pegboard test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute (NCI)		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7931891	Background	Crom WR, de Graaf SS, Synold T, Uges DR, Bloemhof H, Rivera G, Christensen ML, Mahmoud H, Evans WE. Pharmacokinetics of vincristine in children and adolescents with acute lymphocytic leukemia. J Pediatr. 1994 Oct;125(4):642-9. doi: 10.1016/s0022-3476(94)70027-3.
7700168	Background	de Graaf SS, Bloemhof H, Vendrig DE, Uges DR. Vincristine disposition in children with acute lymphoblastic leukemia. Med Pediatr Oncol. 1995 Apr;24(4):235-40. doi: 10.1002/mpo.2950240405.

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007938	Leukemia
D020258	Neurotoxicity Syndromes

ID	Term
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

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