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A Phase II Study of Temozolomide (TMZ) Following Stereotactic Radiosurgery (SRS) for Patients With Newly Diagnosed Brain Metastases

Phase 2
18 Years
Not Enrolling
Brain Metastases

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Trial Information

A Phase II Study of Temozolomide (TMZ) Following Stereotactic Radiosurgery (SRS) for Patients With Newly Diagnosed Brain Metastases

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants Who Developed Distant Brain Failure at One Year.

Outcome Time Frame:

1 Year

Safety Issue:


Principal Investigator

Erin M Dunbar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida


United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

June 2011

Related Keywords:

  • Brain Metastases
  • Brain Metastases
  • Temozolomide
  • Temodar
  • TMZ
  • Stereotactic Radiosurgery
  • SRS
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms



University of Florida Gainesville, Florida  32610-0277