Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms
Intervention: Temozolomide; Radiation therapy
Intervention description: Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles.; Standard whole brain radiation therapy 30 Gy in ten fractions.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; squamous cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; bronchoalveolar cell lung cancer; adenosquamous cell lung cancer; tumors metastatic to brain

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      temozolomide may make the tumor cells more sensitive to radiation therapy. Combining
      temozolomide with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving temozolomide together with
      whole-brain radiation therapy works in treating patients with brain metastasis secondary to
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed non-small cell lung cancer (NSCLC), including the following
             histologies:

               -  Squamous cell carcinoma

               -  Adenocarcinoma

               -  Large cell carcinoma

               -  Bronchoalveolar carcinoma

               -  All variants of NSCLC

          -  At least 1 bidimensionally measurable brain metastasis

               -  Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is
                  not acceptable

               -  Biopsy is not required

               -  Not eligible for surgical resection or radiosurgery of brain metastasis

          -  Systemic disease not in immediate need of chemotherapy

          -  Age>=18 years

          -  ECOG Performance status of 0-1

          -  More than 12 weeks of life expectancy

          -  Adequate hematologic, renal, and liver function as demonstrated by laboratory values
             performed within two weeks, inclusive, prior to administration of study drug or
             registration

               -  Absolute neutrophil count ≥ 1,500/mm^3

               -  Platelet count ≥ 100,000/mm^3

               -  Hemoglobin ≥ 10 g/dL

               -  Bilirubin ≤ 2 times upper limit of normal (ULN)

               -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2 times
                  upper limit of normal (5 times ULN if liver metastases are present)

               -  Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)

               -  Creatinine ≤ 1.6 mg/dL

          -  Fertile patients must use effective contraception

          -  Prior biologic therapy allowed

          -  More than 4 weeks since prior chemotherapy

          -  Prior radiotherapy for local control or palliative therapy for painful bony lesions
             allowed

          -  Prior surgery for brain metastasis allowed

          -  At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for < 15%
             of bone marrow) and recovered

               -  No prior radiotherapy to ≥ 50% of bone marrow

          -  Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of
             bone marrow is irradiated

        Exclusion Criteria:

          -  HIV positive

          -  AIDS-related illness

          -  Poor medical risks due to active nonmalignant systemic disease

          -  Frequent vomiting

          -  There is medical condition that would interfere with oral medication intake (e.g.,
             partial bowel obstruction)

          -  Pregnant or nursing

          -  Prior temozolomide

          -  Prior radiotherapy to the brain, including stereotactic radiosurgery to a different
             lesion

          -  Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy

          -  Other concurrent investigational agents

          -  Other concurrent treatment for brain metastasis

          -  Other concurrent chemotherapy during study radiotherapy

          -  Concurrent growth factors to induce elevations in blood counts for the purposes of
             administration of study drug at scheduled dosing interval or to allow treatment with
             study drug at a higher dose