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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member. 6. For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide. 7. Women of childbearing potential and male participants must practice adequate contraception.

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.
  • - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • - Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • - Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
  • - Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01364064
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

King Faisal Specialist Hospital & Research Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Naseer Al-Rajhi
Principal Investigator Affiliation KFSH & RC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Conventional adjuvant Temozolomide

TMZ d 1-5 of 28-d cycle 6 cycles

Experimental: Dose intensive Temozolomide

TMZ d 1-21 of 28-d cycle 6 cycles

Interventions

Drug: - TMZ

Comparing conventional adjuvant Temozolomide with dose intensive Temozolomide

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.