SarcomaPhase 2NCT00035620
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
A Phase 2 study testing pegfilgrastim and filgrastim in people with Sarcoma and Neutropenia, run by Amgen.
Trial summary
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Sarcoma, Neutropenia
- What is being tested?
- pegfilgrastim and filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Apr 2007
- Phase
- Phase 2
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
- Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
About this study
Official title: A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.
- Conditions
- Sarcoma, Neutropenia
- Being tested
- pegfilgrastim, filgrastim
- Keywords
- Bone cancer, Sarcoma, Neutropenia, Chemotherapy
- Medical subject headings
- Sarcoma, Neutropenia, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegfilgrastimDrug
pegfilgrastim
filgrastimDrug
filgrastim
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Active comparator | Filgrastim Receives: Drug: filgrastim |
| Pegfilgrastim | Experimental | Pegfilgrastim Receives: Drug: pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe neutropenia in chemotherapy in cycles 1 and 3
Measured: cycles 1 and 3
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3
Measured: cycles 1 and 3
Secondary outcomes (3)
Pharmacokinetic profile in chemotherapy cycles 1 and 3
Measured: cycles 1 and 3
Incidence of adverse events across all cycles of chemotherapy
Measured: all cycles
Overall rates of febrile neutropenia
Measured: all cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startApr 2000
- Primary completionJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035620
- Sponsor's protocol ID
- 990130
- Status last verified
- Feb 2010
- First submitted
- 3 May 2002
- Last updated
- 26 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
- ClinicalTrials.gov ID
- NCT00035620
- Acronym / sponsor ID
- 990130
- Conditions
- Sarcoma, Neutropenia
- Keywords
- Bone cancer, Sarcoma, Neutropenia, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 6 May 2002 (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.
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | Active comparator | Drug: filgrastimFilgrastim |
| Pegfilgrastim | Experimental | Drug: pegfilgrastimPegfilgrastim |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| pegfilgrastimpegfilgrastim | Drug | Pegfilgrastim |
| filgrastimfilgrastim | Drug | Filgrastim |
Primary outcome
Duration of severe neutropenia in chemotherapy in cycles 1 and 3
Time frame: cycles 1 and 3
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3
Time frame: cycles 1 and 3
3 secondary outcomes
Pharmacokinetic profile in chemotherapy cycles 1 and 3
Time frame: cycles 1 and 3
Incidence of adverse events across all cycles of chemotherapy
Time frame: all cycles
Overall rates of febrile neutropenia
Time frame: all cycles
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 26 Feb 2010.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegfilgrastim and filgrastim in people with Sarcoma and Neutropenia, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Feb 2010. 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?
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.
What does the primary outcome measure?
Duration of severe neutropenia in chemotherapy in cycles 1 and 3 (time frame: cycles 1 and 3). The study lists 2 primary outcomes in all. 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 26 Feb 2010.