Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma
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 administered orally (a capsule) at approximately the same time daily
(bedtime) for 42 days on and then 14 days off; cycles may be repeated every 56 days.
Complete blood counts will be obtained bi-weekly, evaluations monthly and MRI's every 2
months after a cycle of therapy.
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 (all disease found at staging must be followed using the same modality used
at Pre-treatment. Tumor assessments are to be repeated every 56 days thereafter until
progression). The same procedures are repeated on Day 1 of each treatment cycle with the
addition of an adverse event assessment.
Patients may continue on therapy unless one of the following occurs:
- Documented or clinical progressive disease at any time
- Unacceptable toxicity
- Treatment delay of > 2 weeks for any reason
- Study data or other data indicate that the study treatment is not beneficial for the
patients; defined as at least one response in the first 12 patients within each tumor
- Non-compliance by the patient with protocol requirements (follow-up, treatment,
administration of disallowed therapy)
- Changes in medical status of the patient such that the patient no longer meets
eligibility requirements (leptomeningeal spread, change in mental competency) or the
investigator believes that patient safety will be compromised.
- Patient withdrawal of consent for treatment
- Occurrence of one toxic death
Patients with CR, PR, or stable disease (SD) will be treated for a minimum of 3 cycles [6
months] or until disease progression. For patients responding to treatment, continuation of
therapy beyond 3 cycles is at the discretion of the investigator. Response parameters will
include the MacDonald criteria for evaluating brain tumors. Response is measured by a
reduction in tumor size.
After cessation of protocol therapy, patients will continue to be followed for survival at
2-month intervals for up to three years from start of treatment. 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate overall survival
dependent upon results
Marc Chamberlain, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|