Status:
TERMINATED
Study of Temozolomide to Treat Newly Diagnosed Brain Metastases
Lead Sponsor:
University of Florida
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 f...
Eligibility Criteria
Inclusion
- Tumor characteristics adequate for stereotactic radiosurgery:
- 1-3 newly diagnosed, previously untreated, brain metastases
- Each tumor measuring a size less than or equal to 3 cm
- No other contraindications to stereotactic radiosurgery
- Systemic parameters adequate for temozolomide following stereotactic radiosurgery:
- Histological confirmation of systemic malignancy (brain confirmation not required)
- Male or female 18 years of age or older
- Negative pregnancy test (if of childbearing potential)
- Any number of previous recurrences will be allowed
- Karnofsky Performance Status \> 60
- Hematocrit \> 30,000
- White blood cell count \> 1,500
- Platelet \> 100,000
- Absolute Neutrophil Count \> 1,000
- Bilirubin \< 1.5 x upper limits of normal
- Transaminases (ALT and AST) \< 1.5 x upper limits of normal
- Creatinine \< 1.5 x upper limits of normal
- Adequate medical health to participate in this study
- Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
- Ability to read and understand the informed consent document
- Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms
- No other contraindications to temozolomide (severe organ dysfunction, immunosuppression, etc.)
- Medical stability and/or recovery from effects of stereotactic radiosurgery
Exclusion
- Karnofsky Performance Status \< 60
- Hematocrit \< 30,000
- White blood cell count \< 1,500
- Platelet \< 100,000
- Absolute Neutrophil Count \< 1,000
- Bilirubin \>1.5 x upper limits of normal
- Transaminases (ALT and AST) \> 1.5 x upper limits of normal
- Creatinine \> 1.5 x upper limits of normal
- Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
- Germ cell, leukemia, and lymphoma histologies will be excluded
- Prior chemotherapy or radiotherapy for brain metastases (prior resection and steroids are allowed)
- Contraindications to radiosurgery or temozolomide chemotherapy
- Uncontrolled systemic malignancy
- Chemotherapy or other systemic therapy for systemic malignancy within a specified time of temozolomide initiation, depending on half-life of agent:
- Cytotoxic chemotherapy within the previous 4 weeks
- Nitrosurea (CCNU, BCNU) within the previous 6 weeks
- Gliadel or temozolomide within the previous 4 weeks
- Bevacizumab or other antiangiogenic agent within the previous 4 weeks
- Other targeted molecular or antibody agent within the previous 4 weeks
- Hormonal agent within the previous 2 weeks
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00717275
Start Date
September 1 2008
End Date
June 1 2011
Last Update
October 1 2012
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610