Gastrointestinal Stromal TumorPhase 2NCT00112632
Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
A Phase 2 study testing imatinib mesylate, conventional surgery and neoadjuvant therapy in people with Gastrointestinal Stromal Tumor, run by Technical University of Munich at 9 sites in 2 countries.
Trial summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- imatinib mesylate, conventional surgery and neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2005to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed gastrointestinal stromal tumor
- Locally advanced disease
- Potentially resectable disease*
- No tumor that can be completely resected (R0) with sufficient margins NOTE: *Multivisceral resection may be necessary
- Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry
- At least 1 site of measurable disease
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
Hepatic
- AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
- Bilirubin < 1.5 times ULN
- No chronic active hepatitis
- No cirrhosis
- No other chronic liver disease
Renal
- Creatinine < 1.5 times ULN
- No chronic renal disease
Cardiovascular
- No New York Heart Association class III-IV cardiac disease
- No congestive heart failure
- No myocardial infarction within the past 6 months
Immunology
- No active uncontrolled infection
- No known HIV positivity
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- Must be medically fit to undergo surgery
- No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
- No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
- No uncontrolled diabetes
- No other severe or uncontrolled medical disease
- No significant history of noncompliance to medical regimens
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biologic agents
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
- No concurrent anticancer chemotherapy
Endocrine therapy
- No concurrent systemic corticosteroid therapy unless approved by the study sponsor
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to ≥ 25% of bone marrow
Surgery
- More than 2 weeks since prior major surgery except tumor biopsy
Other
- More than 4 weeks since prior investigational drugs unless disease is rapidly progressing
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent warfarin for therapeutic anticoagulation
- Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed
- Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, D-13122
Universitaetsklinikum Bonn
Bonn, D-53105
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924
University Medical Center Hamburg - Eppendorf
Hamburg, D-20246
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, D-72076
Dr. Horst-Schmidt-Kliniken
Wiesbaden, D-65199
About this study
Official title: Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.
Read the detailed description
OBJECTIVES:
Primary
- Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
- Determine histological response in patients treated with this drug.
Secondary
- Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
- Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.
After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- imatinib mesylate, conventional surgery, neoadjuvant therapy
- Keywords
- gastrointestinal stromal tumor
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumor response (complete response, partial response, stable disease, and progression of disease)
Secondary outcomes (2)
Time to progression of disease
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Licht, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112632
- Sponsor's protocol ID
- CDR0000430499
- Other IDs
- KRDI-TUM-GIST-CST1571-BDE43, EU-20507
- Status last verified
- Mar 2012
- First submitted
- 2 Jun 2005
- Last updated
- 8 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha
- ClinicalTrials.gov ID
- NCT00112632
- Acronym / sponsor ID
- CDR0000430499
- Conditions
- Gastrointestinal Stromal Tumor
- Keywords
- gastrointestinal stromal tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Feb 2005
- First posted
- 3 Jun 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.
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.
Detailed description
OBJECTIVES:
Primary
- Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
- Determine histological response in patients treated with this drug.
Secondary
- Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
- Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.
After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| imatinib mesylate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Overall tumor response (complete response, partial response, stable disease, and progression of disease)
2 secondary outcomes
Time to progression of disease
Overall survival
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 8 Mar 2012.
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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.
Thomas Licht, MD study chair
Technical University of Munich
9 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 imatinib mesylate, conventional surgery and neoadjuvant therapy in people with Gastrointestinal Stromal Tumor, run by Technical University of Munich at 9 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?
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 8 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 9 sites in Germany, Austria. 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?
Overall tumor response (complete response, partial response, stable disease, and progression of disease). 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 8 Mar 2012.