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Astrocytoma, Grade II clinical trials

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NCT ID: NCT04304300 Recruiting - Oligodendroglioma Clinical Trials

Radiotherapy in IDH Mutated Glioma: Evaluation of Late Outcomes

RIGEL
Start date: December 10, 2019
Phase:
Study type: Observational

Rationale: Standard postoperative treatment of isocitrate dehydrogenase 1/2 mutated grade 2 and 3 glioma (IDHmG) consists of radiotherapy and chemotherapy. The improving prognosis of these patients leads towards more emphasis on the long-term effects of treatment. Specifically radiotherapy has been implicated in the development of delayed neurocognitive deterioration. The impact of modern radiotherapy techniques (such as intensity modulated radiotherapy, volumetric modulated radiotherapy and proton beam therapy) and chemotherapy on general toxicity, late neurocognitive outcomes and imaging changes is currently unclear. Objectives: - To report treatment outcomes and radiation-induced toxicity from a prospective, multicentre observational cohort of IDHmG patients treated with radiotherapy and chemotherapy, - To integrate radiotherapeutic dose distributions, imaging changes and neuropsychological outcome in IDHmG. - To evaluate the Dutch selection criteria for proton therapy applied to IDHmG based on the outcomes collected in this observational study. - To assess the impact of proton and photon therapy on health-related quality of life (HRQoL) and health-related economics (HR-E) in IDHmG patients. - To collect genetic material for future translational research into the interaction between germline DNA, prognosis and radiation-induced toxicity. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This project is a multicentre, observational cohort of patients undergoing radiotherapy and chemotherapy for IDHmG. The protocol closely follows the local guidelines for clinical follow-up. Specific to the study are extra questionnaires and specific imaging acquired during scheduled MRI's. Routine neuropsychological investigation is standard of care in Erasmus Medical Center (Erasmus MC), but not in all participating centers. We feel the additional burden of participation in this study to be low.

NCT ID: NCT03906448 Terminated - Clinical trials for Astrocytoma, Grade III

FORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma

FORWARD
Start date: May 20, 2019
Phase: Phase 2
Study type: Interventional

This is a phase 2, multi-institutional, historically-controlled, study of 100 patients with newly diagnosed Grade II and III astrocytoma comparing the combination of TTFields with adjuvant temozolomide versus temozolomide alone in historical controls after the completion of definitive chemoradiotherapy. Study treatment may continue past first tumor recurrence. The primary endpoint will be overall survival.

NCT ID: NCT02924038 Terminated - Glioma Clinical Trials

A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)

Start date: April 3, 2017
Phase: Phase 1
Study type: Interventional

This is a pilot, randomized, two arm neoadjuvant vaccine study in human leukocyte antigen-A2 positive (HLA-A2+) adults with World Health Organization (WHO) grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety of the novel combination of subcutaneously administered IMA950 peptides and poly-ICLC (Hiltonol) and i.v. administered CDX-1127 (Varlilumab) in the neoadjuvant approach; and 2) whether addition of i.v. CDX-1127 (Varlilumab) increases the response rate and magnitude of CD4+ and CD8+ T-cell responses against the IMA950 peptides in post-vaccine peripheral blood mononuclear cell (PBMC) samples obtained from participating patients.

NCT ID: NCT02549833 Active, not recruiting - Glioma Clinical Trials

Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma

Start date: October 17, 2016
Phase: Phase 1
Study type: Interventional

This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected glioma.

NCT ID: NCT01836549 Terminated - Glioblastoma Clinical Trials

Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors

Start date: March 2013
Phase: Phase 2
Study type: Interventional

This molecular biology and phase II trial studies how well imetelstat sodium works in treating younger patients with recurrent or refractory brain tumors. Imetelstat sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.