Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma

NCT00365222 | Terminated Phase 2 DMC

• 1 other identifier: MCC-14714
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days. Procedures prior to initial study treatment (\<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast. The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast. Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.

Conditions

Glioblastoma; Gliosarcoma

Keywords

Temozolomide; Temodar; Glioblastoma; Gliosarcoma; Brain Tumor; Quality of Life; Neurological

Outcome Measures

Primary Outcomes (1)

• Evaluate overall survival

  dependent upon results

Secondary Outcomes (4)

• Progression-free survival at six and nine months

  9 months

• Response rate measured by a reduction in tumor size

  9 months

• Frequency and severity of adverse events

  9 months

• Quality of life measured at each cycle utilizing the QOL FACT-BR

  9 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide DRUG

temozolomide 75 mg/m2 /d

Also known as: Temodar

1

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients must have histological documented glioblastoma or gliosarcoma. All patients must have had prior pathologic confirmation of tumor histology.
• Patients must be \> than or equal to 70 years old.
• Patients must have a Karnofsky performance status of \> 50.
• Nonmeasurable disease or measurable disease per MacDonald criteria
• Patients must have a predicted life expectancy of at least 12 weeks.
• Required initial laboratory data: ANC \>1,500, Platelets \>100,000, Serum Creatinine \<2.0, Serum Bilirubin \<2.0, and AST/ALT \<3x normal
• Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required).
• Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.
• Patients must have been previously treated with surgery.
• No prior adjuvant or salvage chemotherapy regimen is permitted.
• Prior radiotherapy is not permitted.

You may not qualify if:

• Patients have evidence of leptomeningeal spread of disease.
• Patients having been treated with prior chemotherapy or radiotherapy.
• Patients with a second active malignancy or diagnosis of other cancer within -3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
• Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.
• Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
• Known to be HIV positive or to have an AIDS-related illness.
• Patients with an active infection that is not adequately controlled with antibiotics.
• Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
• Patients with a known sensitivity to any of the products to be administered during treatment.
• Patients currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.
• Patients previously treated with temozolomide.
• Concurrent radiotherapy.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Schering-Plough: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms; Neurologic Manifestations

Interventions

Temozolomide

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; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marc Chamberlain, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 17, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 22, 2009

Record last verified: 2009-01

Locations

US (1)