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ALECSAT as Add on to Radiotherapy and TMZ in Patients With Newly Diagnosed Glioblastoma

2016-06-14 17:38:21 | BioPortfolio

Summary

This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma.

Up to 87 patients with newly diagnosed glioblastoma will be enrolled in the study in a 1:2 allocation (SOC: ALECSAT as an adjunct therapy to SOC).

Data from a further 29 patients gathered from an ongoing observational study of glioblastoma patients treated according to SOC at Sahlgrenska University hospital in Göteborg, Sweden will be used as historical control data and combined with the randomised control data in performing the statistical analysis.

Patients recruited into this study will receive either:

- ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or

- Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma

Intervention

ALECSAT, radiotherapy, Temozolomide

Location

Sahlgrenska University Hospital
Göteborg
Sweden

Status

Recruiting

Source

CytoVac A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-14T17:38:21-0400

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Medical and Biotech [MESH] Definitions

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

The total amount of radiation absorbed by tissues as a result of radiotherapy.

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

Radiotherapy where there is improved dose homogeneity within the tumor and reduced dosage to uninvolved structures. The precise shaping of dose distribution is achieved via the use of computer-controlled multileaf collimators.

Radiotherapy where cytotoxic radionuclides are linked to antibodies in order to deliver toxins directly to tumor targets. Therapy with targeted radiation rather than antibody-targeted toxins (IMMUNOTOXINS) has the advantage that adjacent tumor cells, which lack the appropriate antigenic determinants, can be destroyed by radiation cross-fire. Radioimmunotherapy is sometimes called targeted radiotherapy, but this latter term can also refer to radionuclides linked to non-immune molecules (see RADIOTHERAPY).

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