Nimotuzumab in Adults With Glioblastoma Multiforma

Oncoscience

Status and phase: Completed; Phase 3

Conditions: Adults With Glioblastoma Multiforma

Treatments: Drug: nimotuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00753246

OSAG101-BSA05

Details and patient eligibility

About

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Full description

The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient signed informed consent

• Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV

• Condition is measurable by MRI in at least one dimension

• Age 18-70

• Karnofsky-Index > 40

• Treatment in a study center

• Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.

• Adequate haematological, renal and hepatic function:

  • Leucocytes >2.0x10^9/l
  • Hb> 10g/dl
  • Billirubin total < 2.5x upper limit of normal (ULN)
  • Creatinin i.S. < 1.5x ULN
  • AST (GOT)/ALT (GPT) < 5x ULN

Exclusion criteria

• Patients with history of anaphylactic reaction to murine or humanized antibody
• Patients with evidence second malignancy
• Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
• Pregnancy and lactation
• Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
• No MRI for tumour evaluation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups, including a placebo group

Arm B

Placebo Comparator group

Description:

adults with TMZ, RT

Treatment:

Drug: nimotuzumab

Arm A

Experimental group

Description:

adults with TMZ, RT, nimotuzumab

Treatment:

Drug: nimotuzumab