Brain Metastases
Conditions
Keywords
Brain Metastases, Temozolomide, Temodar, TMZ, Stereotactic Radiosurgery, SRS
Brief summary
The purpose of this study is to determine if administering temozolomide after completion of stereotactic radiosurgery helps control existing brain metastases and prevents the developement of new brain metastases.
Detailed description
Brain metastases represent a heterogenous group of system tumors whose presence in the central nervous system result in profound neurological devastation. Existing therapies for brain metastases are focused on improving both neurologic function and survival. Therapies aimed at controlling the tumor both at the site of the brain metastases and the rest of the brain have the potential to improve outcomes and quality of life. The combined use of stereotactic radiosurgery followed by temozolomide may represent such a strategy.
Interventions
DRUGTemozolomide
75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Tumor characteristics adequate for stereotactic radiosurgery: 1. 1-3 newly diagnosed, previously untreated, brain metastases 2. Each tumor measuring a size less than or equal to 3 cm 3. No other contraindications to stereotactic radiosurgery Systemic parameters adequate for temozolomide following stereotactic radiosurgery: 1. Histological confirmation of systemic malignancy (brain confirmation not required) 2. Male or female 18 years of age or older 3. Negative pregnancy test (if of childbearing potential) 4. Any number of previous recurrences will be allowed 5. Karnofsky Performance Status \> 60 6. Hematocrit \> 30,000 7. White blood cell count \> 1,500 8. Platelet \> 100,000 9. Absolute Neutrophil Count \> 1,000 10. Bilirubin \< 1.5 x upper limits of normal 11. Transaminases (ALT and AST) \< 1.5 x upper limits of normal 12. Creatinine \< 1.5 x upper limits of normal 13. Adequate medical health to participate in this study 14. Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal) 15. Ability to read and understand the informed consent document 16. Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms 17. No other contraindications to temozolomide (severe organ dysfunction, immunosuppression, etc.) 18. Medical stability and/or recovery from effects of stereotactic radiosurgery
Exclusion criteria
1. Karnofsky Performance Status \< 60 2. Hematocrit \< 30,000 3. White blood cell count \< 1,500 4. Platelet \< 100,000 5. Absolute Neutrophil Count \< 1,000 6. Bilirubin \>1.5 x upper limits of normal 7. Transaminases (ALT and AST) \> 1.5 x upper limits of normal 8. Creatinine \> 1.5 x upper limits of normal 9. Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis 10. Germ cell, leukemia, and lymphoma histologies will be excluded 11. Prior chemotherapy or radiotherapy for brain metastases (prior resection and steroids are allowed) 12. Contraindications to radiosurgery or temozolomide chemotherapy 13. Uncontrolled systemic malignancy 14. Chemotherapy or other systemic therapy for systemic malignancy within a specified time of temozolomide initiation, depending on half-life of agent: 1. Cytotoxic chemotherapy within the previous 4 weeks 2. Nitrosurea (CCNU, BCNU) within the previous 6 weeks 3. Gliadel or temozolomide within the previous 4 weeks 4. Bevacizumab or other antiangiogenic agent within the previous 4 weeks 5. Other targeted molecular or antibody agent within the previous 4 weeks 6. Hormonal agent within the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Developed Distant Brain Failure at One Year. | 1 Year |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the investigator's clinical practice between September 2008 and January 2011.
Participants by arm
| Arm | Count |
|---|---|
| Temozolomide Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Premature study termination. | 3 |
Baseline characteristics
| Characteristic | Temozolomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Number of Participants Who Developed Distant Brain Failure at One Year.
Time frame: 1 Year
Population: Data was not analyzed.