Wilms TumorPhase 2NCT00187031
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
A Phase 2 study testing Topotecan, Filgrastim (G-CSF), Pegfilgrastim in people with Wilms Tumor, run by St. Jude Children's Research Hospital at 7 sites in 2 countries.
Trial summary
In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Wilms Tumor
- What is being tested?
- Topotecan, Filgrastim (G-CSF), Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2002to Oct 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
Who may be able to join
- Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
- Age< 21 years of age at the time of study entry
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Adequate performance status
Who cannot join
- Subject is pregnant
- Subject is lactating
- Renal tumors other than Wilms tumors
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Children's Healthcare
Atlanta, Georgia, 30301
Dana Farber
Boston, Massachusetts, 02115-6084
Baylor College of Medicine
Houston, Texas, 77030
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Canada3 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Alberta Children's Hospital
Calgary, Alberta, T2W 3N2
Hospital of Sick Children
Toronto, Ontario, M5G 1X8
About this study
In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.
Read the detailed description
Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.
Secondary Objectives include:
- To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.
- To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
- To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
- Conditions
- Wilms Tumor
- Being tested
- Topotecan, Filgrastim (G-CSF), Pegfilgrastim
- Keywords
- Wilms Tumor
- Medical subject headings
- Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topotecan, Filgrastim (G-CSF), PegfilgrastimDrug
See detailed description section for additional details.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (complete and partial response as per RECIST criteria).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2002
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wilms TumorStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, National Institutes of Health (NIH)
- Investigators
- Monika Metzger, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187031
- Sponsor's protocol ID
- WILTOP
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Metzger ML, Stewart CF, Freeman BB 3rd, Billups CA, Hoffer FA, Wu J, Coppes MJ, Grant R, Chintagumpala M, Mullen EA, Alvarado C, Daw NC, Dome JS. Topotecan is active against Wilms' tumor: results of a multi-institutional phase II study. J Clin Oncol. 2007 Jul 20;25(21):3130-6. doi: 10.1200/JCO.2007.10.9298.
PubMed 17634492
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
- ClinicalTrials.gov ID
- NCT00187031
- Acronym / sponsor ID
- WILTOP
- Conditions
- Wilms Tumor
- Keywords
- Wilms Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, National Institutes of Health (NIH)
- Study start
- Nov 2002
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Sep 2005 (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.
In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.
Detailed description
Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.
Secondary Objectives include:
- To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.
- To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
- To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
- Age< 21 years of age at the time of study entry
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
Key exclusion criteria (3 listed)
- Subject is pregnant
- Subject is lactating
- Renal tumors other than Wilms tumors
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 |
|---|---|---|
| Topotecan, Filgrastim (G-CSF), PegfilgrastimSee detailed description section for additional details. | Drug | 1 |
Primary outcome
Response rate (complete and partial response as per RECIST criteria).
Time frame: 5 years
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 Jun 2008.
- Background: PubMed 17634492Metzger ML, Stewart CF, Freeman BB 3rd, Billups CA, Hoffer FA, Wu J, Coppes MJ, Grant R, Chintagumpala M, Mullen EA, Alvarado C, Daw NC, Dome JS. Topotecan is active against Wilms' tumor: results of a multi-institutional phase II study. J Clin Oncol. 2007 Jul 20;25(21):3130-6. doi: 10.1200/JCO.2007.10.9298.
- St. Jude Children's Research HospitalLink 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.
Monika Metzger, MD principal investigator
St. Jude Children's Research Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topotecan, Filgrastim (G-CSF), Pegfilgrastim in people with Wilms Tumor, run by St. Jude Children's Research Hospital at 7 sites in 2 countries.
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 6 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 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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 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?
Response rate (complete and partial response as per RECIST criteria). (time frame: 5 years). 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 NCT00187031, which also lists 1 linked publication.
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 Jun 2008.