Phase II study: Systemic treatment with alternating weekly regimen of temozolomide and monthly fotemustine combination in recurrent glioblastoma patients. - ND

• Conditions: Glioblastoma recurrent; MedDRA version: 9.1Level: LLTClassification code 10018336Term: Glioblastoma

• Registration Number: EUCTR2008-001645-26-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1.Signed and dated IRB-approved Informed Consent. 2.Histologically proven (at diagnosis) Glioblastoma Multiforme (GBM) 3.Recurrence or progression after treatment with surgery, radiotherapy and chemotherapy, including temozolomide 4.Age more between 18 years 5.KPS 18 and 70 years enclosed 6.Life expectancy of at least 12 weeks 7.Negative pregnancy test (if female in reproductive age) 8.Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation, if men and women of child-producing potential 9.Acceptable liver function: - Bilirubin  1.5 upper limit of normal (ULN) - Albumin  3.0 g/dL - AST (SGOT), ALT (SGPT)  2.5 ULN (if liver metastases are present, then  5 ULN is allowed) - Alkaline phosphatase  2.5 ULN (if liver and/or bone metastases are present, then  5 ULN is allowed) 10.Acceptable renal function: Serum creatinine ≤1.5 mg/dl (or ≤133 µmol/L) 11.Acceptable hematologic status: - ANC  1,500 cells/mm3 - Platelet count  100,000 cells/mm3 - Hemoglobin  10.0 g/dL 12.At the time of first dose of study combination, at least 4 weeks must have elapsed since completion of prior temozolomide therapy, prior radiotherapy, prior surgery (at least 6 weeks since completion of prior nitrosurea therapy) 13.With the exception of alopecia, resolution of all acute toxic effects of any prior surgery, radiotherapy, radiosurgery or chemotherapy to NCI CTC (Version 3.0) Grade < 1 and to the baseline laboratory values as defined in Inclusion Criteria Number 9, 10, 11. 14.All patients on treatment with anticonvulsants, should continue the anticonvulsant therapy with non-enzyme-inducing anticonvulsants (non-EIACs) 15.Concurrent steroids allowed, dose stable for at least 7 days before study entry 16.Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol 17.Presence of at least one  1.5 cm2 bi-dimensionally measurable lesion by gadolinium (Gd)-enhanced MRI scan, indicating progressive or recurrent disease, obtained at least 12 weeks after standard external-beam radiotherapy and within 14 days prior to treatment. 18.Patients in relapse, following 1st line chemotherapy including temozolomide.
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

The presence of any of the following will exclude a subject from study enrollment: 1.Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1 2.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 3.Pregnant or breast feeding women 4.Known infection with HIV, active hepatitis B or hepatitis C 5.Prior high-dose chemotherapy with bone marrow or stem cell support 6.Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri. 7.Current enrollment in another therapeutic clinical trial 8.Patients who have exhibited allergic reactions to temozolomide or fotemustine 9.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified