OsteosarcomaPhase 2NCT00634322
High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma
A Phase 2 study testing glucarpidase and leucovorin in people with Osteosarcoma, run by BTG International Inc..
Trial summary
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- glucarpidase and leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Apr 2009
- Phase
- Phase 2
- 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 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- osteosarcoma
- eligible to receive 2 sequential cycles of HDMTX-LV
Who cannot join
- prior administration of glucarpidase
- progression of disease while on previous MTX treatment
About this study
Official title: Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV
- Conditions
- Osteosarcoma
- Being tested
- glucarpidase, leucovorin
- Keywords
- osteosarcoma, high dose methotrexate, leucovorin
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucarpidaseDrug
Also called Voraxaze, caboxypeptidase G2, CPG2
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
leucovorinDrug
Also called LV
IV or po given every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | HDMTX-LV with glucarpidase Receives: Drug: glucarpidase |
| B | Active comparator | HDMTX-LV with placebo Receives: Drug: leucovorin |
| C | Experimental | compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment Receives: Drug: glucarpidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Progressing to Next Chemotherapy Cycle
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionApr 2009
Why it stopped: Lack of enrollment
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTG International Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Pete Anderson, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634322
- Sponsor's protocol ID
- PR001-CLN-pro012
- Other IDs
- MDACC #2006-0246
- Status last verified
- Sep 2014
- First submitted
- 6 Mar 2008
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma
- ClinicalTrials.gov ID
- NCT00634322
- Acronym / sponsor ID
- PR001-CLN-pro012
- Conditions
- Osteosarcoma
- Keywords
- osteosarcoma, high dose methotrexate, leucovorin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BTG International Inc.University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: glucarpidaseHDMTX-LV with glucarpidase |
| B | Active comparator | Drug: leucovorinHDMTX-LV with placebo |
| C | Experimental | Drug: glucarpidasecompassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- osteosarcoma
- eligible to receive 2 sequential cycles of HDMTX-LV
Key exclusion criteria (2 listed)
- prior administration of glucarpidase
- progression of disease while on previous MTX treatment
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 |
|---|---|---|
| glucarpidaseAlso: Voraxaze, caboxypeptidase G2, CPG2IV dose based on weight, two doses given for 5 minutes, 24 hours apart | Drug | A, C |
| leucovorinAlso: LVIV or po given every 6 hours | Drug | B |
Primary outcome
Patients Progressing to Next Chemotherapy Cycle
Time frame: 1 week after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pete Anderson, MD, PhD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glucarpidase and leucovorin in people with Osteosarcoma, run by BTG International Inc..
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 2 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: stopped early, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Sep 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?
Patients Progressing to Next Chemotherapy Cycle (time frame: 1 week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2014.