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Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

NCT ID: NCT00717275

Last Updated: 2012-10-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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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

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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

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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

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Brain Metastases

Keywords

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Brain Metastases Temozolomide Temodar TMZ Stereotactic Radiosurgery SRS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Temodar TMZ

Eligibility Criteria

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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

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin M Dunbar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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METS-001

Identifier Type: -

Identifier Source: org_study_id