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Nimotuzumab in Adults With Glioblastoma Multiforma

Study Purpose

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00753246
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Oncoscience AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Manfred Westphal, Prof. MD
Principal Investigator Affiliation University Hamburg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, Other
Overall Status Completed
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adults With Glioblastoma Multiforma
Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Arm B

adults with TMZ, RT

Experimental: Arm A

adults with TMZ, RT, nimotuzumab

Interventions

Drug: - nimotuzumab

monoclonal antibody

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Dep. Neurosurgery, Univ. Hamburg, Hamburg, Germany

Status

Address

Dep. Neurosurgery, Univ. Hamburg

Hamburg, , 20246

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