Expired Study
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Buffalo, New York 14263


Purpose:

RATIONALE: Ammonium tetrathiomolybdate may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving ammonium tetrathiomolybdate together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving radiation therapy together with ammonium tetrathiomolybdate in treating patients with stage I, stage II, or stage III non-small cell lung cancer.


Study summary:

OBJECTIVES: Primary - To assess the acute toxicity of combining antiangiogenic copper reduction with ammonium tetrathiomolybdate (TM) and standard external-beam radiotherapy in patients with stage I-IIIB non-small cell lung cancer. Secondary - To measure changes in biological markers of angiogenesis (i.e., ELISA analysis of serum bFGF, VEGF, TGF-beta, IL-6, and IL-8) affected by TM or radiotherapy and an imaging technique (technetium 99m sestamibi) known to correlate with intratumoral angiogenesis. - To follow the late toxicity that exists when angiogenic inhibition with the copper reduction agent TM is combined with standard external-beam radiotherapy in these patients. - To collect tumor response, recurrence rate, and survival data on these patients. OUTLINE: - Induction phase: Patients receive oral ammonium tetrathiomolybdate (TM) 4 times daily for up to 3 weeks. - Radiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6-7 weeks along with concurrent TM. - Maintenance phase: Patients continue to receive TM for a total of 1 year . Blood is collected periodically for analysis of laboratory outcomes by ELISA and technetium 99m sestamibi scans. Biomarkers may include VEGF, bFGF, TGF-beta, interleukin (IL)-6, and IL-8. After completion of study therapy, patients are followed every 3 months for up to 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria: - Squamous, large cell undifferentiated, or adenocarcinoma - Sputum cytology not acceptable evidence of cell type - Cytologic specimens obtained by brushing, washing, or needle aspiration of a defined lesion allowed - Stage I-IIIB disease - No evidence of distant metastases - Planning to receive definitive radiotherapy alone or post-operative radiotherapy (for gross residual disease or positive margin) - Medically inoperable disease or chemotherapy or surgery refused - Mediastinal lymph nodes must be evaluated by either mediastinoscopy or by PET scan, unless definitive CT-positive mediastinal disease is noted - If patient cannot tolerate mediastinoscopy and no PET is available, the technetium 99m sestamibi scan is allowed for assessment of the mediastinum - No stage IIIB disease with pleural effusions or stage IV disease - No small cell lung cancer or mixed small cell/non-small cell histology PATIENT CHARACTERISTICS: - SWOG performance status 0-2 - Hemoglobin ≥ 9.0 g/dL - WBC ≥ 3,000/mm³ - ANC ≥ 1,200/mm³ - Platelet count ≥ 80,000/mm³ - Creatinine < 1.8 mg/dL - Prior malignancy allowed if disease free for ≥ 5 years - Nonmelanoma skin cancer allowed within 5 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No grade 3 hemoptysis (or hemoptysis not requiring transfusion, but where the radiation oncologist has concerns about a 3-week delay in treatment) - No pneumonia due to bronchial obstruction (or a high-grade bronchial obstruction where the radiation oncologist has concerns about a 3-week delay in treatment) - No transfusion dependence requiring > 2 units of packed RBCs every 2 weeks for more than 28 days - No medically serious acute or chronic medical condition that is unstable and/or requires intensive management PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Prior thoracic radiation allowed if the new lesion can be treated with absolutely no overlap of previous treatment fields - At least 3 weeks since prior surgery - No concurrent chemotherapy


NCT ID:

NCT00560495


Primary Contact:

Principal Investigator
Mohammad K. Khan, MD, PhD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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