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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-02-29

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).

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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)

Intervention Type PROCEDURE

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