Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00717275
• Other study ID #: METS-001
• Status: Terminated
• Phase: Phase 2
• First received: July 15, 2008
• Last updated: September 14, 2012
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Temozolomide
75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Developed Distant Brain Failure at One Year.		1 Year	No