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Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00717275
First received: July 15, 2008
Last updated: September 14, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Brain Metastases
 Drug: Temozolomide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of Participants Who Developed Distant Brain Failure at One Year. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717275

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00717275     History of Changes
Other Study ID Numbers: METS-001
Study First Received: July 15, 2008
Results First Received: July 10, 2012
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Brain Metastases
Temozolomide
Temodar
 TMZ
Stereotactic Radiosurgery
SRS

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

ClinicalTrials.gov processed this record on May 22, 2013