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Second line therapy with low dose fotemustine in progressive malignant gliomas - fotgm

Second line therapy with low dose fotemustine in progressive malignant gliomas - fotgm

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003342-29-IT
Enrollment
Unknown
Registered
2008-06-04
Start date
2007-10-31
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive malignant gliomas patients MedDRA version: 9.1 Level: LLT Classification code 10006131 Term: Brain neoplasm malignant

Interventions

Trade Name: MUPHORAN Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Fotemustine Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Sponsors

ISTITUTI FISIOTERAPICI OSPITALIERI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Anaplastic gliomas Measurable disease Previous treatment including alkilating agent Age > 18 years Karnofsky PS >= 60 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Presence of cardiac disease Previous radiotherapy within 60 days Previous treatment with fotemustine or other nitrosurees

Design outcomes

Primary

MeasureTime frame
Main Objective: Activity in terms of response rate and time to progression;Secondary Objective: Tolerability MGMT methilation and relationship with efficacy;Primary end point(s): Response rate Time to progression—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026