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Study of Temozolomide to Treat Newly Diagnosed Brain Metastases
This study is currently recruiting participants.
Verified by University of Florida, April 2009
First Received: July 15, 2008   Last Updated: April 23, 2009   History of Changes
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00717275
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Determine the 1-year actuarial risk of death from all causes and risk of death from brain failure. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the longitudinal effect of oral temozolomide on traditional performance status and quality of life measurements. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Evaluate the longitudinal tolerability of temozolomide using standardized toxicity criteria. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Temozolomide: Experimental Drug: Temozolomide
75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.

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

Contacts
Contact: Christine Keeling, BSN, OCN 352.273.7981 christine.keeling@neurosurgery.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Christine Keeling, BSN, OCN     352-273-7981     christine.keeling@neurosurgery.ufl.edu    
Principal Investigator: Erin M Dunbar, MD            
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 ( Erin M. Dunbar, MD )
Study ID Numbers: METS-001
Study First Received: July 15, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00717275     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases
Antineoplastic Agents, Alkylating
Central Nervous System Neoplasms
Brain Diseases
Alkylating Agents
Temozolomide
Nervous System Neoplasms

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

ClinicalTrials.gov processed this record on September 10, 2009