Imatinib in Patients With Desmoid Tumor and Chondrosarcoma (Basket 1)
Primary Purpose
Advanced Desmoid Tumor, Advanced Chondrosarcoma
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Imatinib Mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Desmoid Tumor focused on measuring PDGFr alpha, PDGFr beta, KIT
Eligibility Criteria
Inclusion Criteria:
- Histological diagnosis of DT or CDS.
- Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
- Measurable or evaluable disease
- Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease.
- ECOG Performance status 0, 1, 2 or 3
- Adequate bone marrow, liver and renal function
- Female patients of child-bearing potential must have negative pregnancy test.
- Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
- Written, voluntary, informed consent.
Exclusion Criteria:
- Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
- Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- Known brain metastasis.
- Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion.
- Major surgery within 2 weeks prior to study entry.
- Expected non-compliance to medical regimens (e.g. psychiatric diseases).
Sites / Locations
- Centro di Riferimento Oncologico - Unit of Medical Oncology
- I.R.C.C. - Unit of Medical Oncology
- Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
- Policlinico S.Orsola Malpighi - Unit of Medical Oncology
- Istituto Nazionale Tumori - Unit of Medical Oncology
- Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
- Ospedale Gradenigo - Unit of Medical Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imatinib Mesylate
Arm Description
Patients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
Outcomes
Primary Outcome Measures
Tumor response will be evaluated by different imaging techniques
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00928525
Brief Title
Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Acronym
Basket 1
Official Title
Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2007 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italian Sarcoma Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Desmoid Tumor, Advanced Chondrosarcoma
Keywords
PDGFr alpha, PDGFr beta, KIT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imatinib Mesylate
Arm Type
Experimental
Arm Description
Patients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
Intervention Type
Drug
Intervention Name(s)
Imatinib Mesylate
Intervention Description
800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
Primary Outcome Measure Information:
Title
Tumor response will be evaluated by different imaging techniques
Time Frame
every three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological diagnosis of DT or CDS.
Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ)
Measurable or evaluable disease
Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease.
ECOG Performance status 0, 1, 2 or 3
Adequate bone marrow, liver and renal function
Female patients of child-bearing potential must have negative pregnancy test.
Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
Written, voluntary, informed consent.
Exclusion Criteria:
Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing
Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ.
Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
Known brain metastasis.
Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
Known diagnosis of human immunodeficiency virus (HIV) infection.
Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion.
Major surgery within 2 weeks prior to study entry.
Expected non-compliance to medical regimens (e.g. psychiatric diseases).
Facility Information:
Facility Name
Centro di Riferimento Oncologico - Unit of Medical Oncology
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
I.R.C.C. - Unit of Medical Oncology
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Nazionale Tumori - Unit of Medical Oncology
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Ospedale Gradenigo - Unit of Medical Oncology
City
Torino
ZIP/Postal Code
10153
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
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