Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate

Study Overview
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Brief Summary
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The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

Official Title
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Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

Conditions
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Cancer

Intervention / Treatment
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* Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 1 )
* Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 2)
* Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 3)
* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rare tumor metastatic disease or locally advanced disease, inoperable, with no standard treatment At least 28 days since the prior treatment Measurable disease with at least one measurable lesion Exclusion Criteria: Medullary insufficiency Cystitis, haemorrhagic cystitis Hepatic porphyria

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 1 )|CYCLE 1 (42 days): Day 1 to 14 Imatinib mesylate : 400 mg/day, per os Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os NEXT CYCLE (28 days): Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os|
|Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 2)|CYCLE 1 (42 days): Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os NEXT CYCLE (28 days): Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os|
|Drug: Imatinib mesylate, Cyclophosphamide (Dosing level 3)|CYCLE 1 (42 days): Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os NEXT CYCLE (28 days): Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os|
|Procedure: Blood sampling|ONLY FOR CYCLE 1, at day 15 and day 28 : 11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For safety: NCI-CTCAE scale version 3.0 |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For anti tumoral efficiency : RECIST criteria |  | 70 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermatofibrosarcoma, cylindroma, choroid melanoma, gastrointestinal stroma tumor, chordoma, ocular melanoma, conjunctival melanoma, malignant melanoma of the anus, gastric melanoma, desmoid tumor