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Neuro-oncologie (tumeur cérébrale)

Pour plus d’informations sur les essais cliniques sur la tumeur cérébrale, veuillez contacter Isabelle Desloges at isabelle.desloges@mcgill.ca
 

Études actuelles en recrutement

Étude ouverte de phase 3 et à répartition aléatoire visant à évaluer l’efficacité potentielle et l’innocuité de l’éflornithine associée à la lomustine comparativement à la lomustine en monothérapie chez des patients atteints d’un astrocytome anaplasique qui progresse ou récidive après une radiothérapie et une chimiothérapie adjuvante par témozolomide

De clinicaltrials.gov. Malheureusement, les informations ne sont disponibles qu’en anglais. Pour plus d’informations en français, veuillez contacter Salma Khalil.

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

This study will consist of 4 study periods of up to 50 months in total, consisting of:

Screening Period – A maximum screening duration of 4 weeks.

Treatment Period – Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit – A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period – Up to 24 months.

A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Plus d’information

Étude de phase III multicentrique et randomisée de radiothérapie peropératoire dans le cas du glioblastome multiforme nouvellement diagnostiqué

De clinicaltrials.gov. Malheureusement, les informations ne sont disponibles qu’en anglais. Pour plus d’informations en français, veuillez contacter Salma Khalil.

INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.

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A Phase II Trial of Concurrent Sunitinib, Temozolomide and Radiation Therapy followed by Adjuvant Sunitinib and Temozolomide for Newly Diagnosed Glioblastoma Patients with an Unmethylated MGMT Gene Promoter.Principal Investigator: Bassam Abdulkarim Phone: 514-934-1934, x43594 (MGH) Email: bassam.abdulkarim@mcgill.ca

Études actives (ne recrutent pas)

Étude de phase III à répartition aléatoire et à simple insu visant à évaluer l’association témozolomide et radiothérapie administrée en concomitance avec le nivolumab ou un placebo chez des sujets adultes ayant récemment reçu un diagnostic de glioblastome exprimant une forme méthylée du gène MGMT (O6-méthylguanine ADN méthyltransférase)

De clinicaltrials.gov. Malheureusement, les informations ne sont disponibles qu’en anglais. Pour plus d’informations en français, veuillez contacter Salma Khalil.

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.

Plus d’information

Étude ouverte à répartition aléatoire de phase 3 comparant le nivolumab et le témozolomide chacun en association avec la radiothérapie chez les patients ayant récemment reçu un diagnostic de glioblastome porteur d’un gène MGMT (tumeur O6-méthylguanine ADN méthyltransférase) non méthylé

De clinicaltrials.gov. Malheureusement, les informations ne sont disponibles qu’en anglais. Pour plus d’informations en français, veuillez contacter Salma Khalil.

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

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Essai clinique de phase III portant sur DCVax®-L, un produit à base de cellules dendritiques autologues combinées à un antigène obtenu d’un lysat tumoral pour le traitement du glioblastome multiforme (GBM).

De clinicaltrials.gov. Malheureusement, les informations ne sont disponibles qu’en anglais. Pour plus d’informations en français, veuillez contacter Salma Khalil.

The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

This Phase III trial is designed to evaluate the impact on disease progression and survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The experimental therapy uses a patient’s own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to “teach” the immune system how to recognize brain cancer cells. Eligible patients will receive a series of injections of DCVax-L, to activate and then boost the immune response to the tumor cells.

The primary study endpoint is PFS (progression free survival), and the first secondary endpoint is overall survival (OS). Other endpoints include performance status, immune response, and also safety. Interim analyses to assess efficacy are incorporated in the trial design.

Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain, swelling at the injection site.

Plus d’information

Étude ouverte randomisée de Phase 2/3 portant sur Toca 511, un vecteur rétroviral réplicatif, utilisé en association avec Toca FC, comparativement au traitement standard chez les sujets qui subissent une résection planifiée d’un glioblastome ou d’un astrocytome anaplasique récurrent.

De clinicaltrials.gov. Malheureusement, les informations ne sont disponibles qu’en anglais. Pour plus d’informations en français, veuillez contacter Salma Khalil.

This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator’s choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient’s Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process.

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