Lung Cancer Clinical Trial

Radiation Therapy and Ammonium Tetrathiomolybdate in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Summary

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.

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Full Description

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.

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Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Study ID:

NCT00560495

Recruitment Status:

Withdrawn

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

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Study is for people with:

Lung Cancer

Phase:

Phase 1

Study ID:

NCT00560495

Recruitment Status:

Withdrawn

Sponsor:


Roswell Park Cancer Institute

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