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

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

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).

Intervention(s) in this Clinical Trial

• 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)

Primary Measures

• For safety: NCI-CTCAE scale version 3.0
  • Time Frame: 42 days
    Safety Issue?: Yes

Secondary Measures

• For anti tumoral efficiency : RECIST criteria
  • Time Frame: 70 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Centre Oscar Lambret Other

Overall Clinical Trial Officials and Contacts

Antoine ADENIS, MD, PhD Principal Investigator Centre Oscar Lambret  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01046487

Study ID Number: 2008-004212-12

ClinicalTrials.gov Identifier: NCT01046487

Health Authority: France: Afssaps - French Health Products Safety Agency