Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma (FOLAGLI)
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|ClinicalTrials.gov Identifier: NCT01700569|
Recruitment Status : Unknown
Verified August 2016 by Institut Cancerologie de l'Ouest.
Recruitment status was: Recruiting
First Posted : October 4, 2012
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Grade IV Astrocytoma Glioblastoma||Drug: Temozolomide Drug: folinic acid at pharmacological dose is the escalated drug Radiation: High voltage radiation therapy (linear accelerator)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Escalated Pharmacologic Dose, of Oral Folinic Acid in Combination With Temozolomide, According to Stupp R. Regimen, in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT.|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: Folinic Acid
Folinic acid is given orally every day during the radiation therapy (47 days), then 5 days at each of the 6 maintenance cycle of temozolomide. The dose is escalated in a "3x3" method and the levels are: 5mg, 10mg, 15mg, 30mg, 60mg.
All the Patients are treated by oral Temozolomide 75 mg/m²/day every day during 42 days, 30 minutes after Folinic acid and 120 min before the radiation dose to the brain tumor. After one month rest, the maintenance phase consists of:Temozolomide is given orally (30 min after Folinic acid), at 200 mg/m²/day every day during 5 days: one course every month during 6 months (6 maintenance course).
Drug: folinic acid at pharmacological dose is the escalated drug
Other Name: Folinate de Calcium, Lederfoline
Radiation: High voltage radiation therapy (linear accelerator)
Brain tumor field is irradiated Five days a week, during Stupp regimen during 6 weeks. During the sams time, Folinic acid and Temozolomide are given orally every days (six weeks).
- Maximal Tolerated Dose [ Time Frame: day 43 ]maximal tolerated dose 3x3 patients inclusion(modified Fibonnacci dose escalation )
- MGMT gene re-methylation [ Time Frame: day 43 ]
- Overall Survival [ Time Frame: Year 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700569
|Contact: Francois PEIN, MDemail@example.com|
|ICO site Gauducheau||Recruiting|
|Nantes, France, 44805|
|Contact: Mario Campone, MD, PhD +33240679900 firstname.lastname@example.org|
|Principal Investigator: Mario CAMPONE, MD, PhD|
|Sub-Investigator: Jean S FRESNEL, MD|
|Principal Investigator:||Mario CAMPONE, MD, PhD||Institut Cancerologie de l'Ouest|