Neoplasms

All Conditions

Rare Diseases

Glioblastoma

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Glioma

Neoplasms, Neuroepithelial

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Temozolomide

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).

Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.

Anlotinib Hydrochloride

Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.

Radiation therapy

Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.

Heming Lu, MD

For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma

Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study

First Affiliated Hospital of Guangxi Medical University

Cancer Hospital of Guangxi Medical University

Liuzhou Workers Hospital

Nanxishan Hospital

LiuZhou People's Hospital

Affiliated Hospital of Guilin University

People's Hospital of Guangxi

Professor

Vaccines

Induction phase: 4 weekly doses of dendritic cell vaccine (10x10exp6 cells) intradermally administered (weeks 1-4).

Maintenance phase: 28 days cycles with vaccine administration (start on week 7) and adjuvant temozolomide (150-200mg/m2/day) assumed orally from day 1 to 5 q28 (start on week 5). The combined maintenance treatment will continue until disease progression, unacceptable toxicity or withdrawal of consent by the patient, or up to a maximum of 1 year of treatments.

After disease progression or the end of maintenance phase, is foreseen a one-year follow-up phase for each subject.

10×10exp6 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

Autologous Dendritic Cells (DC) vaccine

Adjuvant temozolomide assumed orally from day 1 to 5 (start on week 5). Dosage: 150mg/m2/day for the first cycle and 200 mg/m2/day for subsequent cycles (q28).

Oriana Nanni, DR

Anna Miserocchi, DR

Laura Ridolfi, DR

Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).

Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).

The experimental treatment consists of an induction phase with 4 weekly doses of dendritic cell vaccine (10x10exp6 cells) intradermally administered (weeks 1-4), followed by a maintenance phase consisting of 28 days cycles with vaccine administration (start on week 7) and adjuvant temozolomide (150-200mg/m2/day) assumed orally from day 1 to 5 q28 (start on week 5). The combined maintenance treatment will continue until disease progression, unacceptable toxicity or withdrawal of consent by the patient, or up to a maximum of 1 year of treatments. After disease progression or the end of maintenance phase, is foreseen a one-year follow-up phase for each subject.

Primary objectives are clinical activity and safety of the study treatment. Secondary objectives are the evaluation of the prognostic role of the positive Delayed-Type Hypersensitivity (DTH) skin test after at least four vaccine administrations, the OS and the immunological efficacy of the study treatment. A series of exploratory objectives will be also assessed on samples from patients who participate to this optional part of the trial.

Simon's two-stage design (Simon, 1989) will be used for the sample size calculation.

A planned interim analysis will be done after the recruitment of the first 9 evaluable patients for toxicity and for efficacy.

If study will not be stopped due to lack of safety or efficacy, a total of 28 evaluable patients will be enrolled for the trial.

Time to events (PFS and OS) will be calculated with the Kaplan-Meier method and the analysis was performed on the eligible population. For the primary objective, the proportion of patients without progression at three months from leukapheresis date will be evaluated. The proportion of patients experiencing vaccine-related grade ≥ 3 adverse events (AEs) during the treatment will be inferred by means of the two-sided Clopper-Pearson, or a more appropriate one, 95% confidence interval. Descriptive statistics will be used to assess the extent of the secondary endpoints.

Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma

Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma: a Phase II Study

Progression free survival (PFS), measured as the proportion of patients without progression of disease at three months from leukapheresis

Proportion of patients experienced grade 3 or higher adverse events related to the study treatment

Evaluation of the prognostic role of a positive DTH test after at least four vaccine administrations

Overall Survival (OS) is calculated as the time from the date of leukapheresis to the date of death for any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive.

Immunological efficacy: ability to enhance the proportion of circulating immune effectors specific for tumor antigens; evaluation of the persistence of an anti-tumor immune response; determination of plasma levels of a panel of inflammatory cytokines and pro-angiogenic factors; evaluation of the prognostic and predictive role of tumor antigen expression in tumor tissue; analysis of the prognostic and predictive role of immune cells in the peripheral blood and in the tumor microenvironment

Explorative endpoint (optional participation for patients): HLA class I and II characterization of patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma	NCT04157478	Glioblastoma	Anlotinib Hydro... Radiation thera... Temozolomide	18 Years - 75 Years	People's Hospital of Guangxi
Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma	NCT04523688	Glioblastoma Vaccination	Autologous Dend... Temozolomide	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for stupp regimen