Adult FibrosarcomaPhase 2NCT00084630
Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans
A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Adult Fibrosarcoma and Dermatofibrosarcoma Protuberans, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Fibrosarcoma, Dermatofibrosarcoma Protuberans, Recurrent Adult Soft Tissue Sarcoma
- What is being tested?
- imatinib mesylate and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed diagnosis of either dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP; patients with transformed fibrosarcomatous DFSP may have primary, locally recurrent or metastatic disease; patients with DFSP must have locally recurrent or metastatic disease OR primary disease for which complete excision with a wide margin (> 1-2 cm) would result in unacceptable cosmetic disfigurement or functional impairment
- Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed
- Pathology materials must be submitted for review; failure to submit pathology materials will render the patient ineligible
- Patients must be willing to have blood samples submitted for testing of drug levels; also, it is strongly recommended that patients submit fresh/frozen tumor tissue that will yield 0.5 grams (0.5 cubic centimeters) for molecular correlative studies related to the PDGFR pathway
- Patient must not have had chemotherapy, biologic therapy or investigational agents for this tumor within 28 days prior to registration
- Patients may have received prior major surgery for this disease; at least 14 days must have elapsed since the surgery and the patient must have recovered from all side effects associated with surgery; biopsy of dermatofibrosarcoma protuberans is not considered major surgery and a 14-day delay after biopsy is not required
Show all 20Show fewer
- Prior radiotherapy is allowed, provided at least four weeks have elapsed since the last treatment, there is evidence of progressive disease within or measurable disease outside of the radiation field, and the patient must have recovered from all associated toxicities at the time of registration
- Patients must have Zubrod performance status of =< 2
- WBC >= 2,000/uL
- ANC >= 1,500/uL
- Platelets >= 100,000/uL
- Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN)
- Serum transaminase (SGOT or SGPT) must be =< 2.5 x IULN
- Serum albumin must be >= 2.5 mg/dl
- Patients must not be taking therapeutic doses of coumadin (Warfarin) at the time of registration; patients requiring therapeutic anticoagulation may use heparin, low molecular weight heparin or other agents; mini-dose coumadin (1 mg orally every day as prophylaxis is allowed
- Patients with known CNS metastases are not eligible
- Pregnant or nursing women may not participate on this study; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with imatinib; male/female patients of reproductive potential must also agree to employ an effective contraceptive barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patients registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study have been entered into the database
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Imatinib (NSC-716051) in Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma). Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the response rate (confirmed complete and confirmed partial response) in patients with locally advanced or metastatic dermatofibrosarcoma protuberans (DFSP) treated with imatinib.
II. To estimate the one-year progression-free survival probability in this population when treated with imatinib.
III. To evaluate the frequency and severity of toxicities associated with this treatment.
IV. To measure the presence of PDGFB gene rearrangement in DFSP detectable by RT-PCR (for COL1A1-PDGFB fusions) and/or FISH (PDGFB rearrangements with unknown partners) and explore relationships between these measures and survival and tumor response in a preliminary manner.
- To investigate in a preliminary fashion the correlation of plasma levels of imatinib after 1 month of treatment with the response of DFSP.
VI. To obtain tumor material for additional future correlative studies of the activity of intracellular kinases, cDNA microarray analyses and PDGFB receptor gene sequence analyses.
OUTLINE:
Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses.
Patients are followed every 6 months for 2 years and then annually for 3 years.
- Conditions
- Adult Fibrosarcoma, Dermatofibrosarcoma Protuberans, Recurrent Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Being tested
- imatinib mesylate, laboratory biomarker analysis
- Medical subject headings
- Fibrosarcoma, Dermatofibrosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Also called CGP 57148, Gleevec, Glivec
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses. Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (confirmed complete and confirmed partial response)
Measured: Up to 5 years
Progression-free survival
Measured: At 1 year
Frequency and severity of toxicity as assessed by NCI CTCAE version 3.0
Measured: Up to 5 years after completion of treatment
Relationship between PDGFB and survival
Measured: At baseline and at the time of progression
Secondary outcomes (1)
Relationship between PDGFB and tumor response to imatinib mesylate
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startMay 2004
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult FibrosarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott Schuetze, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084630
- Sponsor's protocol ID
- NCI-2012-03184
- Other IDs
- S0345, U10CA032102, CDR0000365465
- Status last verified
- Feb 2013
- First submitted
- 10 Jun 2004
- Last updated
- 28 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Imatinib (NSC-716051) in Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
- ClinicalTrials.gov ID
- NCT00084630
- Acronym / sponsor ID
- NCI-2012-03184
- Conditions
- Adult Fibrosarcoma, Dermatofibrosarcoma Protuberans, Recurrent Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2004
- Primary completion
- Jul 2007 (actual)
- First posted
- 11 Jun 2004 (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.
This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma). Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed description
PRIMARY OBJECTIVES:
- To assess the response rate (confirmed complete and confirmed partial response) in patients with locally advanced or metastatic dermatofibrosarcoma protuberans (DFSP) treated with imatinib.
II. To estimate the one-year progression-free survival probability in this population when treated with imatinib.
III. To evaluate the frequency and severity of toxicities associated with this treatment.
IV. To measure the presence of PDGFB gene rearrangement in DFSP detectable by RT-PCR (for COL1A1-PDGFB fusions) and/or FISH (PDGFB rearrangements with unknown partners) and explore relationships between these measures and survival and tumor response in a preliminary manner.
- To investigate in a preliminary fashion the correlation of plasma levels of imatinib after 1 month of treatment with the response of DFSP.
VI. To obtain tumor material for additional future correlative studies of the activity of intracellular kinases, cDNA microarray analyses and PDGFB receptor gene sequence analyses.
OUTLINE:
Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses.
Patients are followed every 6 months for 2 years and then annually for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Drug: imatinib mesylate, Other: laboratory biomarker analysisPatients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must have histologically confirmed diagnosis of either dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP; patients with transformed fibrosarcomatous DFSP may have primary, locally recurrent or metastatic disease; patients with DFSP must have locally recurrent or metastatic disease OR primary disease for which complete excision with a wide margin (> 1-2 cm) would result in unacceptable cosmetic disfigurement or functional impairment
- Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed
- Pathology materials must be submitted for review; failure to submit pathology materials will render the patient ineligible
- Patients must be willing to have blood samples submitted for testing of drug levels; also, it is strongly recommended that patients submit fresh/frozen tumor tissue that will yield 0.5 grams (0.5 cubic centimeters) for molecular correlative studies related to the PDGFR pathway
- Patient must not have had chemotherapy, biologic therapy or investigational agents for this tumor within 28 days prior to registration
Key exclusion criteria (0 listed)
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: CGP 57148, Gleevec, GlivecGiven orally | Drug | Treatment (imatinib mesylate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (imatinib mesylate) |
Primary outcome
Response rate (confirmed complete and confirmed partial response)
Time frame: Up to 5 years
Progression-free survival
Time frame: At 1 year
Frequency and severity of toxicity as assessed by NCI CTCAE version 3.0
Time frame: Up to 5 years after completion of treatment
Relationship between PDGFB and survival
Time frame: At baseline and at the time of progression
1 secondary outcome
Relationship between PDGFB and tumor response to imatinib mesylate
Time frame: Up to 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 28 Feb 2013.
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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 principal investigator
SWOG Cancer Research Network
1 site 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 and laboratory biomarker analysis in people with Adult Fibrosarcoma and Dermatofibrosarcoma Protuberans, run by National Cancer Institute (NCI) at 1 site 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 20 inclusion and 0 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 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 (confirmed complete and confirmed partial response) (time frame: Up to 5 years). The study lists 4 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 28 Feb 2013.