Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717275
Recruitment Status : Terminated (Slow accrual.)
First Posted : July 17, 2008
Results First Posted : July 12, 2012
Last Update Posted : October 1, 2012
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Drug: Temozolomide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide (TMZ) Following Stereotactic Radiosurgery (SRS) for Patients With Newly Diagnosed Brain Metastases
Study Start Date : September 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Temozolomide Drug: Temozolomide
75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.
Other Names:
  • Temodar
  • TMZ

Primary Outcome Measures :
  1. Number of Participants Who Developed Distant Brain Failure at One Year. [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00717275

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: Erin M Dunbar, MD University of Florida

Responsible Party: University of Florida Identifier: NCT00717275     History of Changes
Other Study ID Numbers: METS-001
First Posted: July 17, 2008    Key Record Dates
Results First Posted: July 12, 2012
Last Update Posted: October 1, 2012
Last Verified: July 2012

Keywords provided by University of Florida:
Brain Metastases
Stereotactic Radiosurgery

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents