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Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma

Phase 2
70 Years
Not Enrolling
Glioblastoma, Gliosarcoma

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Trial Information

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
histology strata

- 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.

Inclusion Criteria:

- 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 Criteria:

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate overall survival

Outcome Time Frame:

dependent upon results

Safety Issue:


Principal Investigator

Marc Chamberlain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

June 2007

Related Keywords:

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



H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612