Thymic CarcinomaPhase 1NCT00314873
Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
A Phase 1 study testing Gleevec (imatinib) in people with Thymic Carcinoma, run by Indiana University at 1 site in United States.
Trial summary
This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymic Carcinoma
- What is being tested?
- Gleevec (imatinib)
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2011
- Phase
- Phase 1
- 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
- Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease
- Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
- No prior imatinib therapy.
- Age > 18 years at the time of consent
- ECOG performance status of 0 or 1
- ANC ≥ 1500/mm3,Platelet count ≥ 100,000/mm,Total bilirubin < 1.5ULN,3.10 Serum creatinine ≤ 1.7 mg/dl,ALT and AST ≤ 3 x ULN
Who cannot join
- Clinically significant infections as judged by the treating investigator
- Clinically significant concurrent illnesses
- Females of childbearing potential not using birth control or breastfeeding
- Prior radiation therapy > 25% of the bone marrow
- Symptomatic brain metastasis
- History of Grade III/IV cardiac problems
- History of major surgery within 14 days prior to being registered
- Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.
Read the detailed description
Thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. This necessitates the need for systemic therapy. Due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.To this point, there has not been a study using imatinib in thymic tumors expressing the KIT tyrosine kinase protein or PDGF tyrosine kinase protein. This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.
- Conditions
- Thymic Carcinoma
- Being tested
- Gleevec (imatinib)
- Keywords
- Thymic malignancy, Thymic Carcinoma
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gleevec (imatinib)Drug
Imatinib 600mg po qd X 21 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.
Measured: baseline through progression
To determine the duration of remission of patients with thymic carcinoma treated with imatinib.
Measured: baseline through progression
To determine the toxicity of imatinib in this patient population.
Measured: baseline through end of study
To determine the incidence of kit mutations in thymic malignancies.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic CarcinomaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Loehrer, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314873
- Sponsor's protocol ID
- 0603-21/ IUCRO-0147
- Status last verified
- May 2014
- First submitted
- 13 Apr 2006
- Last updated
- 3 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Imatinib (Gleevec) as Treatment for Advanced Thymic Carcinoma
- ClinicalTrials.gov ID
- NCT00314873
- Acronym / sponsor ID
- 0603-21/ IUCRO-0147
- Conditions
- Thymic Carcinoma
- Keywords
- Thymic malignancy, Thymic Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Apr 2006 (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 study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.
Detailed description
Thymic carcinomas are particularly more concerning due to their aggressive metastatic nature and shorter overall survival, in comparison to their lesser-malignant thymoma counterparts. This necessitates the need for systemic therapy. Due to the paucity of thymic carcinoma cases, the ideal regimen for locally advanced or metastatic thymic carcinomas is not defined.To this point, there has not been a study using imatinib in thymic tumors expressing the KIT tyrosine kinase protein or PDGF tyrosine kinase protein. This study is important to demonstrate if single agent activity is noted for patients with thymic tumors over expressing c-kit and/or PDGF. If this current trial is positive, it opens the door to evaluate other combination of drugs with imatinib in thymic tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological or cytological proof of advanced C-KIT positive or PDGFR positive thymic carcinoma. For protocol purposes, advanced disease is defined as disease
- Patient must have at least one documented measurable lesion obtained by imaging within 28 days prior to being registered for protocol therapy.
- No prior imatinib therapy.
- Age > 18 years at the time of consent
- ECOG performance status of 0 or 1
Key exclusion criteria (8 listed)
- Clinically significant infections as judged by the treating investigator
- Clinically significant concurrent illnesses
- Females of childbearing potential not using birth control or breastfeeding
- Prior radiation therapy > 25% of the bone marrow
- Symptomatic brain metastasis
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 |
|---|---|---|
| Gleevec (imatinib)Imatinib 600mg po qd X 21 days. | Drug | – |
Primary outcome
To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma.
Time frame: baseline through progression
To determine the duration of remission of patients with thymic carcinoma treated with imatinib.
Time frame: baseline through progression
To determine the toxicity of imatinib in this patient population.
Time frame: baseline through end of study
To determine the incidence of kit mutations in thymic malignancies.
Time frame: baseline
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 3 Jun 2014.
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A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
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Phase II Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
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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.
Patrick Loehrer principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gleevec (imatinib) in people with Thymic Carcinoma, run by Indiana University 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 6 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 3 Jun 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine the objective response rate of imatinib in patients with c-kit or PDGF positive thymic carcinoma. (time frame: baseline through progression). 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 3 Jun 2014.