Status:
TERMINATED
Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Schering-Plough
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 resect...
Detailed Description
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). Temozolomide will be admi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00365222
Start Date
July 1 2006
End Date
June 1 2007
Last Update
January 22 2009
Active Locations (1)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612