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Completed

NCT Number: NCT00190424

Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Lariboisiere, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Glioblastoma
  • Karnofsky Performance Status ≥ 60%

Exclusion criteria

  • Severe or uncontrolled systemic disease
  • Active auto-immune disease
  • Uncontrolled epilepsia
  • Platelets < 100 000/mm3 ; or Neutrophils <500 /mm3 ; or lymphocytes <300/ mm3

Treatment and study plan

CpG-ODN

Drug

Primary outcomes

  1. Survival

    Time frame: 2 years

Secondary outcomes

  1. Progression-free survival

    Time frame: 2 years

  2. Tolerance

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Sep 19, 2005
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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