OsteosarcomaPhase 1LVPKNCT00634504

Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

A Phase 1 study testing glucarpidase, high-dose methotrexate, leucovorin and high-dose methotrexate, leucovorin in people with Osteosarcoma and Leukemia, run by BTG International Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze. Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteosarcoma, Leukemia, Lymphoma
What is being tested?: glucarpidase, high-dose methotrexate, leucovorin and high-dose methotrexate, leucovorin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 25 sitesUnited States
Study dates: May 2008to Aug 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
Require intravenous leucovorin

Who cannot join

Arm A only: allergic reactions to lactose
Arm A only: hereditary fructose or galactose intolerance
Arm B only: delayed elimination of MTX

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Children's Hospital for Cancer & Blood Disorders
Aurora, Colorado, 80045
Gabrail Cancer Center
Canton, Ohio, 44718
University of Missouri-Columbia
Columbia, Missouri, 65212
NorthShore University Health System
Evanston, Illinois, 60201
ECU Brody School of Medicine
Greenville, North Carolina, 27834
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of MS Medical Center
Jackson, Mississippi, 39216
University of Kentucky
Lexington, Kentucky, 40536
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68506
Good Samaritan Hospital
Los Angeles, California, 90017
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital of Orange County
Los Angeles, California, 92868
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Oakland's Children's Hospital
Oakland, California, 94609
Stanford University Medical Center & Lucile Packard Children's Hospital
Palo Alto, California, 94304-1812
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Huntsman Cancer Center
Salt Lake City, Utah, 84112
California Pacific Medical Center
San Francisco, California, 94115
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Washington University Medical Center
St Louis, Missouri, 63110
St. Joseph's Hospital
Tampa, Florida, 33607
University of Massachusetts - Umass Memorial Medical Center
Worcester, Massachusetts, 04655

Other trials in United States

About this study

Official title: An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

Conditions: Osteosarcoma, Leukemia, Lymphoma
Being tested: glucarpidase, high-dose methotrexate, leucovorin, high-dose methotrexate, leucovorin
Keywords: high dose methotrexate, Voraxaze, leucovorin, delayed elimination, methotrexate toxicity, rescue, renal insufficiency
Medical subject headings: Osteosarcoma, Leukemia, Lymphoma, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

glucarpidase, high-dose methotrexate, leucovorinDrug
Also called Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin
single intravenous dose
high-dose methotrexate, leucovorinDrug
Also called HDMTX, LV
standard of care, leucovorin every 6 hours

Study groups in NCT00634504
Study group	Role	What they receive
A	Experimental	High-dose methotrexate, leucovorin, and Voraxaze Receives: Drug: glucarpidase, high-dose methotrexate, leucovorin
B	Active comparator	High-dose methotrexate and leucovorin without Voraxaze (glucarpidase) Receives: Drug: high-dose methotrexate, leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK) of Leucovorin
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
Measured: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Aug 2009

First posted13 Mar 2008 (estimated)
Study startMay 2008
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteosarcomaStudies of the same condition, open and under way.
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
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00634504
Sponsor's protocol ID: PR001-CLN-pro017
Acronym: LVPK
Status last verified: May 2022
First submitted: 6 Mar 2008
Last updated: 6 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
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RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
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RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
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All Osteosarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
ClinicalTrials.gov ID: NCT00634504
Acronym / sponsor ID: LVPK / PR001-CLN-pro017
Conditions: Osteosarcoma, Leukemia, Lymphoma
Keywords: high dose methotrexate, Voraxaze, leucovorin, delayed elimination, methotrexate toxicity, rescue, renal insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: BTG International Inc.University, hospital or other
Study start: May 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 13 Mar 2008 (estimated)
Results: Posted 3 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: glucarpidase, high-dose methotrexate, leucovorinHigh-dose methotrexate, leucovorin, and Voraxaze
B	Active comparator	Drug: high-dose methotrexate, leucovorinHigh-dose methotrexate and leucovorin without Voraxaze (glucarpidase)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
Require intravenous leucovorin

Key exclusion criteria (3 listed)

Arm A only: allergic reactions to lactose
Arm A only: hereditary fructose or galactose intolerance
Arm B only: delayed elimination of MTX

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
glucarpidase, high-dose methotrexate, leucovorinAlso: Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorinsingle intravenous dose	Drug	A
high-dose methotrexate, leucovorinAlso: HDMTX, LVstandard of care, leucovorin every 6 hours	Drug	B

Primary outcome

Pharmacokinetics (PK) of Leucovorin
Time frame: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.

Results and safety

Results posted to the registry on 3 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A (High-dose Methotrexate, Leucovorin, and Glucarpidase)	11	10
B (High-dose Methotrexate and Leucovorin Without Glucarpidase)	9	9

Primary outcome: Pharmacokinetics (PK) of Leucovorin

Time frame: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration. Geometric mean (95% Confidence Interval). Unit: micromol x hour/L

Measure	A (High-dose Methotrexate, Leucovorin, and Glucarpidase) n = 8	B (High-dose Methotrexate and Leucovorin Without Glucarpidase) n = 9
Value	6.43 (2.89 to 14.32)	1.13 (0.72 to 1.75)

Population analysed: 3 participants were excluded from the PK population (all from Arm A), hence why the total participants is 17, not 20.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A (High-dose Methotrexate, Leucovorin, and Glucarpidase)	3 of 11 (27.3%)	7 of 11 (63.6%)	Not reported
B (High-dose Methotrexate and Leucovorin Without Glucarpidase)	0 of 9 (0%)	0 of 9 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteosarcoma

RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma

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.

Andrew Saunders, MD study chair

Suzanne Kincaid, CCRA study director

BTG International Inc.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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?

Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Pharmacokinetics (PK) of Leucovorin (time frame: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00634504.

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 6 Jun 2022.