Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Study Overview
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Brief Summary
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This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Detailed Description
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Condition Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases. Not included: Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Official Title
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Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Conditions
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Hypereosinophilic Syndrome, Systemic Mastocytosis, Chronic Myelomonocytic Leukemia, Dermatofibrosarcoma

Intervention / Treatment
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* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin. Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) & preferably within 6 weeks of entry. Exclusion Criteria: Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation). A primary prostate, breast, lung or brain tumour, Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response. Other protocol-defined inclusion / exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imatinib mesylate (STI571)<br> | Drug: imatinib mesylate<br> <br> * Other names: STI571;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy and the safety of imatinib mesylate therapy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of imatinib on quality of life and healthcare resource use |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imatinib mesylate, tyrosine kinases, imatinib sensitivity, Diverse malignancies either associated with, or thought to be associated with, activated tyrosine kinase enzymes, including hypereosinophilic syndrome, systemic mastocytosis, chronic myelomonocytic leukaemia,, dermatofibrosarcoma protuberans and other diseases., Not included:, patients with chronic myeloid leukemia,, some other types of leukemias (abl-mutated), some types of gastrointestinal stromal tumours (c-KIT-positive),, some systemic mastocytosis (if c-KIT D816V mutation),, brain,, prostate,, breast or lung cancers.