Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Brain Tumor, Adult

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Psychotropic Drugs

Anesthetics

Midazolam

Anti-Anxiety Agents

Patients receive light sedation (awake) and undergo craniotomy.

Patients receive intubated general anesthesia and undergo craniotomy.

If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.

Arm I (light sedation)

Arm II (intubated general anesthesia)

James Elder, MD

This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.

PRIMARY OBJECTIVES:

I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.

SECONDARY OBJECTIVES:

I. To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.

V. To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive light sedation (awake) and undergo craniotomy.

ARM II: Patients receive intubated general anesthesia and undergo craniotomy.

After completion of study, patients are followed up at 1month and 1 year.

Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy

A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection

Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.

Compare costs of hospital stay, anesthesia, and surgery

Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.

Will be measured by asking patients about their overall positive experiences, if they understood rationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge

Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability

Tracking will be done using the EMR and follow-up calls

Ohio State University Comprehensive Cancer Center

Principal Investigator

Symptoms and General Pathology

Glioblastoma

Shock

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Temozolomide

Immunomodulating Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive standard treatment with radiation and temozolomide after surgery.

Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy.

( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. )

The first adjunctive temozolomide startes on the day of the fifth gp96 injection.

(150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles)

Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered.

gp96

temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).

radiotherapy

zhixian Gao, Doctor

hua Gao

This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.

RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.

Overall Goals:

- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

- to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.

Secondary Aims:

to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.

A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96

tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen.

A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy	NCT02193568	Adult Brain Tum...	Arm I (light se... Arm II (intubat... Arm II (intubat... Arm II (intubat... Arm I (light se... Arm I (light se...	19 Years -	Ohio State University Comprehensive Cancer Center
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96	NCT03650257	Glioma of Brain	gp96 Temozolomide radiotherapy	18 Years - 75 Years	Cure&Sure Biotech Co., LTD
A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96	NCT03650257	Glioma of Brain	gp96 Temozolomide radiotherapy	18 Years - 75 Years	Cure&Sure Biotech Co., LTD

Spots Global Cancer Trial Database for supratentorial glioma