Dermatofibrosarcoma ProtuberansPhase 2NCT00243191
Neoadjuvant Imatinib in Dermatofibrosarcoma Protuberans
A Phase 2 study testing imatinib mesylate in people with Dermatofibrosarcoma Protuberans, run by Sarcoma Alliance for Research through Collaboration at 4 sites in United States.
Trial summary
The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatofibrosarcoma Protuberans
- What is being tested?
- imatinib mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2006to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ or equal to 18 years of age.
- Suspected or documented diagnosis of dermatofibrosarcoma protuberans (DFSP). Patients with suspected diagnosis of DSFP must have DFSP confirmed by pathology at the local institution prior to dispensing and the start of imatinib.
- Patient is medically able to undergo surgical resection of the DFSP and resection of the DFSP is recommended for clinical management of the disease.
- Patient has at least one site of measurable (macroscopic) disease.
- Performance status 0, 1 or 2 Eastern Cooperative Oncology Group (ECOG) (see Section 7.1).
- Adequate end organ function, defined as the following:
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- total bilirubin < 1.5 x institutional upper limit of normal (ULN), SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L.
- Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Written, voluntary informed consent.
Who cannot join
- Patients who will receive radiation therapy to the site of DFSP prior to resection.
- Patients with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
- Female patients who are pregnant or breast-feeding.
- Patients who have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) that may worsen because of imatinib.
- Patients who have known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patients who have received chemotherapy within 4 weeks prior to study entry.
- Patients who have had a major surgery within 2 weeks prior to study entry. Incisional biopsy or partial excision of dermatofibrosarcoma protuberans to establish the diagnosis and/or to collect pretreatment tumor tissue does not qualify as major surgery.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
MD Anderson Cancer Center
Houston, Texas, 77030
Pennsylvania Onc/Hem Assoc.
Philadelphia, Pennsylvania, 19106
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans
The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.
- Conditions
- Dermatofibrosarcoma Protuberans
- Being tested
- imatinib mesylate
- Keywords
- newly diagnosed or recurrent
- Medical subject headings
- Dermatofibrosarcoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Also called Gleevec
400 mg orally twice a day for 10 - 14 days
| Study group | Role | What they receive |
|---|---|---|
| imatinib mesylate | Other | Not described Receives: Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.
To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.
Measured: Prior to and after 2-weeks of imatinib therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startMay 2006
- Primary completionSep 2009
- Study completionSep 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 Dermatofibrosarcoma ProtuberansStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Schuetze, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243191
- Sponsor's protocol ID
- SARC004
- Status last verified
- Feb 2012
- First submitted
- 20 Oct 2005
- Last updated
- 29 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Short Course of Neoadjuvant Gleevec (Imatinib Mesylate) in Dermatofibrosarcoma Protuberans
- ClinicalTrials.gov ID
- NCT00243191
- Acronym / sponsor ID
- SARC004
- Conditions
- Dermatofibrosarcoma Protuberans
- Keywords
- newly diagnosed or recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sarcoma Alliance for Research through CollaborationUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Posted 29 Mar 2012
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 examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imatinib mesylate | Other | Drug: imatinib mesylate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ≥ or equal to 18 years of age.
- Suspected or documented diagnosis of dermatofibrosarcoma protuberans (DFSP). Patients with suspected diagnosis of DSFP must have DFSP confirmed by pathology at the local institution prior to dispensing and the start of imatinib.
- Patient is medically able to undergo surgical resection of the DFSP and resection of the DFSP is recommended for clinical management of the disease.
- Patient has at least one site of measurable (macroscopic) disease.
- Performance status 0, 1 or 2 Eastern Cooperative Oncology Group (ECOG) (see Section 7.1).
Key exclusion criteria (8 listed)
- Patients who will receive radiation therapy to the site of DFSP prior to resection.
- Patients with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
- Female patients who are pregnant or breast-feeding.
- Patients who have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) that may worsen because of imatinib.
- Patients who have known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
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 |
|---|---|---|
| imatinib mesylateAlso: Gleevec400 mg orally twice a day for 10 - 14 days | Drug | imatinib mesylate |
Primary outcome
To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.
Time frame: Prior to and after 2-weeks of imatinib therapy
To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- SARC WebsiteLink 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.
Scott Schuetze, MD, PhD principal investigator
University of Michigan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing imatinib mesylate in people with Dermatofibrosarcoma Protuberans, run by Sarcoma Alliance for Research through Collaboration at 4 sites 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 9 inclusion and 8 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 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 29 Mar 2012). 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?
To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies. (time frame: Prior to and after 2-weeks of imatinib therapy). 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 29 Mar 2012.