Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).

• Age >=18 years.

• Hemoglobin >=10 g/dL.

• White blood cell count >=1.5x10^9/L.

• Platelet count >=100x10^9/L.

• Blood urea <=1.5 x upper limit of normal values (ULN).

• Creatinine <=1.5 x ULN.

• Bilirubin <=1.5 x ULN.

• Aspartate aminotransferase <=3 x ULN.

• Alanine aminotransferase <=3 x ULN.

• Alkaline phosphatase <=2 x ULN.

Exclusion Criteria:

• Tumor-specific pretreatment.

• Contraindication against radiotherapy and/or chemotherapy.

• Malignomas other than basaliomas.

• Existing or planned pregnancy or lactation or inadequate contraception.

• Psychiatric disease.

• Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.