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

NCT01364064 | Completed Phase 3 DMC

• 1 other identifier: RAC#2081-018
• Study Type: interventional
• Target: 1,153
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• safety and efficacy

  5 years

Study Arms (2)

Conventional adjuvant Temozolomide

ACTIVE COMPARATOR

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

Drug: TMZ

Dose intensive Temozolomide

EXPERIMENTAL

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

Drug: TMZ

Interventions

TMZ DRUG

Comparing conventional adjuvant Temozolomide with dose intensive Temozolomide

Conventional adjuvant Temozolomide; Dose intensive Temozolomide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide.
• \. Women of childbearing potential and male participants must practice adequate contraception.

You may not qualify if:

• 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).
• Recurrent or multifocal malignant gliomas
• Metastases detected below the tentorium or beyond the cranial vault.
• 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.
• Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead
• Radiation Therapy Oncology Group: collaborator

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Naseer Al-Rajhi

  KFSH & RC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 25, 2016

Record last verified: 2013-09