Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

NCT ID: NCT00717275

Last Updated: 2012-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-06-30

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.

Conditions

Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

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

Interventions

Temozolomide

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

Intervention Type: DRUG

Other Intervention Names

Temodar; TMZ

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin M Dunbar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

METS-001

Identifier Type: -

Identifier Source: org_study_id