Acute Lymphocytic LeukemiaPhase 1NCT00001689
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
A Phase 1 study testing Vincristine in people with Acute Lymphocytic Leukemia and Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphocytic Leukemia, Leukemia
- What is being tested?
- Vincristine
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Nov 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Acute Lymphocytic Leukemia, Leukemia
- Being tested
- Vincristine
- Keywords
- Neurotoxicity, A.L.L., Limited Sampling, Dose Individualization, Vinca Alkaloids
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJan 1998
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001689
- Sponsor's protocol ID
- 980053
- Other IDs
- 98-C-0053
- Status last verified
- Nov 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 7931891de 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.
PubMed 7700168Adamson PC, Poplack DG, Balis FM. Pharmacology and drug resistance in childhood lymphoblastic leukemia. Hematol Oncol Clin North Am. 1990 Oct;4(5):871-94.
PubMed 2262483
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia
- ClinicalTrials.gov ID
- NCT00001689
- Acronym / sponsor ID
- 980053
- Conditions
- Acute Lymphocytic Leukemia, Leukemia
- Keywords
- Neurotoxicity, A.L.L., Limited Sampling, Dose Individualization, Vinca Alkaloids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 1998
- Study completion
- Nov 2003
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vincristine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7931891Crom 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.
- Background: PubMed 7700168de 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.
- Background: PubMed 2262483Adamson PC, Poplack DG, Balis FM. Pharmacology and drug resistance in childhood lymphoblastic leukemia. Hematol Oncol Clin North Am. 1990 Oct;4(5):871-94.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vincristine in people with Acute Lymphocytic Leukemia and Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001689, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.