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Conventional Adjuvant Temozolomide With Dose Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Conventional Adjuvant Temozolomide With Dose Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT01364064•King Faisal Specialist Hospital & Research Center

View on ClinicalTrials.gov

Summary

This is a Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma.

Detailed Description

Primary objective is to determine if dose-intensifying (increasing the "dose-density") the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Karnofsky performance status of ≥ 60. 2. Age ≥ 18 years. 4. CBC/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below:
•Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.
•Platelets ≥ 100,000 cells/mm3.
•Hemoglobin ≥ 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
•Adequate renal function, as defined below:
•BUN ≤ 25 mg/dl within 14 days prior to study registration
•Creatinine ≤ 1.7 mg/dl within 14 days prior to study registration 4. Adequate hepatic function, as defined below:
•Bilirubin ≤ 2.0 mg/dl within 14 days prior to study registration
•ALT ≤ 3 x normal range within 14 days prior to study registration
•AST ≤ 3 x normal range within 14 days prior to study registration 5. Patients must sign a study-specific informed consent prior to study registration.
+3 more criteria

Exclusion Criteria

•1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
•2. Recurrent or multifocal malignant gliomas
•3. Metastases detected below the tentorium or beyond the cranial vault.
•4. Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
•5. Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
•6. Severe, active co-morbidity, defined as follows:
•* Unstable angina and/or congestive heart failure requiring hospitalization
•* Transmural myocardial infarction within the last 6 months
•* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
+4 more criteria

Key Dates

Start Date

January 1, 2007

Primary Completion Date

June 1, 2008

Completion Date

June 1, 2008

Last Updated

February 25, 2016

Enrollment

1,153

ACTUAL participants

Conditions

Glioblastoma

Interventions

TMZ

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Conventional Adjuvant Temozolomide With Dose Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma